OLYMPUS CK-MB REAGENT— 510(k) K971817

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K971817 for OLYMPUS CK-MB REAGENT, Substantially Equivalent on 1997-06-11. Applicant: Olympus America, Inc.. Device class: 1.

Clearance details

Applicant: Olympus America, Inc.
Product code: Code JLB
Device class: Class 1
Regulation: 21 CFR 862.1210
Advisory panel: Clinical Chemistry
Date received: 1997-05-16
Decision date: 1997-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, 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.