VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS— 510(k) K022901

Name: FDA 510(k) clearance K022901
Creator: U.S. Food and Drug Administration
Published: 2002-09-27

Substantially Equivalent

Ortho-Clinical Diagnostics

FDA 510(k) clearance K022901 for VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS, Substantially Equivalent on 2002-09-27. Applicant: Ortho-Clinical Diagnostics. Device class: 2.

Clearance details

Applicant: Ortho-Clinical Diagnostics
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 2002-09-03
Decision date: 2002-09-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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