OLYMPUS CREATINE KINASE REAGENT— 510(k) K922459

Substantially Equivalent

Olympus Corp.

FDA 510(k) clearance K922459 for OLYMPUS CREATINE KINASE REAGENT, Substantially Equivalent on 1992-07-13. Applicant: Olympus Corp.. Device class: 2.

Clearance details

Applicant: Olympus Corp.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1992-05-26
Decision date: 1992-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

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