GAMMA FETAL BLEED SCREENING TEST— 510(k) K820647

Substantially Equivalent

Gamma Biologicals, Inc.

FDA 510(k) clearance K820647 for GAMMA FETAL BLEED SCREENING TEST, Substantially Equivalent on 1982-05-12. Applicant: Gamma Biologicals, Inc..

Clearance details

Applicant: Gamma Biologicals, Inc.
Product code: Code LIM
Advisory panel: Hematology
Date received: 1982-03-09
Decision date: 1982-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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