CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED— 510(k) K910147

Name: FDA 510(k) clearance K910147
Creator: U.S. Food and Drug Administration
Published: 1991-03-11

Substantially Equivalent

Olympus Corp.

FDA 510(k) clearance K910147 for CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED, Substantially Equivalent on 1991-03-11. Applicant: Olympus Corp.. Device class: 2.

Clearance details

Applicant: Olympus Corp.
Product code: Code CGX
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 1991-01-14
Decision date: 1991-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, NY, US

Download summary PDF View on FDA.gov ↗

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