DCA 2000 SYSTEM FOR HEMOGLOBIN A1C— 510(k) K951361

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K951361 for DCA 2000 SYSTEM FOR HEMOGLOBIN A1C, Substantially Equivalent on 1995-05-05. Applicant: Heraeus Kulzer, Inc..

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code LCP
Advisory panel: Hematology
Date received: 1995-03-27
Decision date: 1995-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mishawaka, IN, US

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