REFLOTRON CREATINE KINASE TEST TABS— 510(k) K904102

Name: FDA 510(k) clearance K904102
Creator: U.S. Food and Drug Administration
Published: 1990-09-27

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K904102 for REFLOTRON CREATINE KINASE TEST TABS, Substantially Equivalent on 1990-09-27. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1990-09-06
Decision date: 1990-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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