HEMAGEN CMV IGG KIT— 510(k) K944438

Substantially Equivalent

Hemagen Diagnostics, Inc.

FDA 510(k) clearance K944438 for HEMAGEN CMV IGG KIT, Substantially Equivalent on 1997-02-20. Applicant: Hemagen Diagnostics, Inc..

Clearance details

Applicant: Hemagen Diagnostics, Inc.
Product code: Code LFZ
Advisory panel: Microbiology
Date received: 1994-09-12
Decision date: 1997-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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