FRUCTOSAMINE ABG21 TEST SYSTEM— 510(k) K913614

Name: FDA 510(k) clearance K913614
Creator: U.S. Food and Drug Administration
Published: 1991-12-02

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K913614 for FRUCTOSAMINE ABG21 TEST SYSTEM, Substantially Equivalent on 1991-12-02. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1991-08-13
Decision date: 1991-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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