VIRGO ANCA SCREEN KIT— 510(k) K973822

Substantially Equivalent

Hemagen Diagnostics, Inc.

FDA 510(k) clearance K973822 for VIRGO ANCA SCREEN KIT, Substantially Equivalent on 1997-11-13. Applicant: Hemagen Diagnostics, Inc..

Clearance details

Applicant: Hemagen Diagnostics, Inc.
Product code: Code MOB
Advisory panel: Immunology
Date received: 1997-10-07
Decision date: 1997-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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