RAICHEM BUN RATE REAGENT— 510(k) K012649

Substantially Equivalent

Hemagen Diagnostics, Inc.

FDA 510(k) clearance K012649 for RAICHEM BUN RATE REAGENT, Substantially Equivalent on 2001-10-15. Applicant: Hemagen Diagnostics, Inc..

Clearance details

Applicant: Hemagen Diagnostics, Inc.
Product code: Code CDQ
Advisory panel: Clinical Chemistry
Date received: 2001-08-13
Decision date: 2001-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

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