Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 101
Compare documented facts, dated analyses and evidence that can change your project scope. Confirm applicability with a specialist.
Compare FDA 510(k) Submission Services providers- ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat (K190315): indications, design and recorded evidenceRegulatory decision evidence
- ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine (K200279): indications, design and recorded evidenceRegulatory decision evidence
- ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE (K163370): indications, design and recorded evidenceRegulatory decision evidence
- ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut (K173726): indications, design and recorded evidenceRegulatory decision evidence
- ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut (K150854): indications, design and recorded evidenceRegulatory decision evidence
- ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip (K173704): indications, design and recorded evidenceRegulatory decision evidence
- Immunoassay Blood Test For Amyloid Pathology Assessment (SET) — FDA decisions, comparisons and evidenceFDA record research
- Immunoassay, Insulin-Like Growth Factor Binding Protein-1 (OAM) — FDA decisions, comparisons and evidenceFDA record research
- Immunoglobulin G (IgG) (K221114): indications, design and recorded evidenceRegulatory decision evidence
- Immunoglobulin G (Igg) Infusion System (PKP) — FDA decisions, comparisons and evidenceFDA record research
- Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser (K250159): indications, design and recorded evidenceRegulatory decision evidence
- Immunoglobulin M Kappa Heavy And Light Chain Combined (PDE) — FDA decisions, comparisons and evidenceFDA record research
- Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells (NTR) — FDA decisions, comparisons and evidenceFDA record research
- Impact PEEK Union Nail System (K252657): indications, design and recorded evidenceRegulatory decision evidence
- Impella XR Sheath Set (K202330): indications, design and recorded evidenceRegulatory decision evidence
- Implant, Endosseous, Orthodontic (OAT) — FDA decisions, comparisons and evidenceFDA record research
- Implantcast ic-Bipolar Head System (K191569): indications, design and recorded evidenceRegulatory decision evidence
- Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter (SHI) — FDA decisions, comparisons and evidenceFDA record research
- InActiv Blue (K221547): indications, design and recorded evidenceRegulatory decision evidence
- InSet Total Shoulder System (K241817): indications, design and recorded evidenceRegulatory decision evidence
- InTray GC (K210511): indications, design and recorded evidenceRegulatory decision evidence
- InVision Precision Cardiac Amyloid (K243866): indications, design and recorded evidenceRegulatory decision evidence
- InVision 3T Recharge Operating Suite (K252239): indications, design and recorded evidenceRegulatory decision evidence
- Indego (K171334): indications, design and recorded evidenceRegulatory decision evidence
- Indego(R) (K173530): indications, design and recorded evidenceRegulatory decision evidence
Page 101 of 228