RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM— 510(k) K021194

Substantially Equivalent

Hemagen Diagnostics, Inc.

FDA 510(k) clearance K021194 for RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM, Substantially Equivalent on 2002-07-29. Applicant: Hemagen Diagnostics, Inc..

Clearance details

Applicant: Hemagen Diagnostics, Inc.
Product code: Code DCK
Advisory panel: Immunology
Date received: 2002-04-15
Decision date: 2002-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

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