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.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code JHW
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1996-04-18
Decision date: 1996-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Boehringer Mannheim Corp.

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K984372 — ELECSYS CALCHECK TROPONIN T1998-12-14

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