AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK— 510(k) K951638

Name: FDA 510(k) clearance K951638
Creator: U.S. Food and Drug Administration
Published: 1995-05-02

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K951638 for AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK, Substantially Equivalent on 1995-05-02. Applicant: Organon Teknika Corp.. Device class: 2.

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code JHY
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1995-04-10
Decision date: 1995-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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