RAICHEM PREALBUMIN SPIA— 510(k) K972812

Substantially Equivalent

Hemagen Diagnostics, Inc.

FDA 510(k) clearance K972812 for RAICHEM PREALBUMIN SPIA, Substantially Equivalent on 1997-08-28. Applicant: Hemagen Diagnostics, Inc..

Clearance details

Applicant: Hemagen Diagnostics, Inc.
Product code: Code DDS
Advisory panel: Immunology
Date received: 1997-07-28
Decision date: 1997-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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