MODIFICATION TO RAICHEM CALCIUM REAGENT— 510(k) K022049

Substantially Equivalent

Hemagen Diagnostics, Inc.

FDA 510(k) clearance K022049 for MODIFICATION TO RAICHEM CALCIUM REAGENT, Substantially Equivalent on 2002-07-19. Applicant: Hemagen Diagnostics, Inc..

Clearance details

Applicant: Hemagen Diagnostics, Inc.
Product code: Code CJY
Advisory panel: Clinical Chemistry
Date received: 2002-06-24
Decision date: 2002-07-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Columbia, MD, US

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