ACCU-CHEK A1C HEMOGLOBIN TEST— 510(k) K974491

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K974491 for ACCU-CHEK A1C HEMOGLOBIN TEST, Substantially Equivalent on 1998-05-13. Applicant: Boehringer Mannheim Corp..

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code LCP
Advisory panel: Hematology
Date received: 1997-11-28
Decision date: 1998-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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