VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III— 510(k) K042494

Substantially Equivalent

Ortho-Clinical Diagnostics

FDA 510(k) clearance K042494 for VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III, Substantially Equivalent on 2004-10-19. Applicant: Ortho-Clinical Diagnostics.

Clearance details

Applicant
Ortho-Clinical Diagnostics
Product code
Code CZW
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Rochester, NY, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.