CEDIA(R) FOLATE (NO BOIL) ASSAY— 510(k) K946184

Name: FDA 510(k) clearance K946184
Creator: U.S. Food and Drug Administration
Published: 1995-01-17

Substantially Equivalent

Microgenics Corp.

FDA 510(k) clearance K946184 for CEDIA(R) FOLATE (NO BOIL) ASSAY, Substantially Equivalent on 1995-01-17. 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: 1994-12-20
Decision date: 1995-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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