AXSYM CK-MB— 510(k) K935924

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K935924 for AXSYM CK-MB, Substantially Equivalent on 1994-06-21. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code JHW
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1993-12-13
Decision date: 1994-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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