OPTIMATE HEMOGLOBIN A1C— 510(k) K896830

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K896830 for OPTIMATE HEMOGLOBIN A1C, Substantially Equivalent on 1990-09-11. Applicant: Heraeus Kulzer, Inc..

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code LCP
Advisory panel: Hematology
Date received: 1989-12-04
Decision date: 1990-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

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