Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 225
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- i-STAT TBI Plasma cartridge with the i-STAT Alinity System (K201778): indications, design and recorded evidenceRegulatory decision evidence
- i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials (K133002): indications, design and recorded evidenceRegulatory decision evidence
- i-STAT hs-TnI cartridge with the i-STAT 1 System (K240984): indications, design and recorded evidenceRegulatory decision evidence
- i-Stat Alinity System with i-Stat Glucose test (K163271): indications, design and recorded evidenceRegulatory decision evidence
- i3 Foldable Mobility Scooter (K191356): indications, design and recorded evidenceRegulatory decision evidence
- iBOT Personal Mobility Device (iBOT PMD) (K210920): indications, design and recorded evidenceRegulatory decision evidence
- iBOT® PMD (K243442): indications, design and recorded evidenceRegulatory decision evidence
- iCOquit® Smokerlyzer® (K211918): indications, design and recorded evidenceRegulatory decision evidence
- iChemVELOCITY Automated Urine Chemistry System (K171083): indications, design and recorded evidenceRegulatory decision evidence
- iDart Lyme IgG ImmunoBlot Kit (K233367): indications, design and recorded evidenceRegulatory decision evidence
- iFuse Bedrock Granite Implant System (K253094): indications, design and recorded evidenceRegulatory decision evidence
- iFuse Bedrock Granite Implant System (K220195): indications, design and recorded evidenceRegulatory decision evidence
- iFuse Bedrock Granite® Implant System (K233508): indications, design and recorded evidenceRegulatory decision evidence
- iFuse TORQ TNT Implant System (K241504): indications, design and recorded evidenceRegulatory decision evidence
- iFuse TORQ® Implant System (K241574): indications, design and recorded evidenceRegulatory decision evidence
- iHealth COVID-19 Antigen Rapid Test (K233842): indications, design and recorded evidenceRegulatory decision evidence
- iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip (K241394): indications, design and recorded evidenceRegulatory decision evidence
- iHearTest (K151025): indications, design and recorded evidenceRegulatory decision evidence
- iMESH Tacker (K153202): indications, design and recorded evidenceRegulatory decision evidence
- iNSitu Bipolar Hip System (K191297): indications, design and recorded evidenceRegulatory decision evidence
- iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating (K243192): indications, design and recorded evidenceRegulatory decision evidence
- iNSitu Total Hip System (K191936): indications, design and recorded evidenceRegulatory decision evidence
- iNSitu Total Hip System (K192071): indications, design and recorded evidenceRegulatory decision evidence
- iPEP System and vPEP (K160636): indications, design and recorded evidenceRegulatory decision evidence
- iPETcertum (v1.0) (K244016): indications, design and recorded evidenceRegulatory decision evidence
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