CEDIA RED BLOOD CELL FOLATE REAGENT PACK— 510(k) K921689

Name: FDA 510(k) clearance K921689
Creator: U.S. Food and Drug Administration
Published: 1992-06-16

Substantially Equivalent

Microgenics Corp.

FDA 510(k) clearance K921689 for CEDIA RED BLOOD CELL FOLATE REAGENT PACK, Substantially Equivalent on 1992-06-16. Applicant: Microgenics Corp.. Device class: 2.

Clearance details

Applicant: Microgenics Corp.
Product code: Code CGN
Device class: Class 2
Regulation: 21 CFR 862.1295
Advisory panel: Clinical Chemistry
Date received: 1992-04-08
Decision date: 1992-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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