ELECSYS CK-MB— 510(k) K961501

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K961501 for ELECSYS CK-MB, Substantially Equivalent on 1996-06-11. Applicant: Boehringer Mannheim Corp..

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code JHW
Advisory panel: Clinical Chemistry
Date received: 1996-04-18
Decision date: 1996-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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