RAICHEM CREATININE URINE STANDARD— 510(k) K011126

Substantially Equivalent

Hemagen Diagnostics, Inc.

FDA 510(k) clearance K011126 for RAICHEM CREATININE URINE STANDARD, Substantially Equivalent on 2001-05-02. Applicant: Hemagen Diagnostics, Inc..

Clearance details

Applicant: Hemagen Diagnostics, Inc.
Product code: Code JIT
Advisory panel: Clinical Chemistry
Date received: 2001-04-13
Decision date: 2001-05-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Columbia, MD, US

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