GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS— 510(k) K861016

Substantially Equivalent

Gamma Biologicals, Inc.

FDA 510(k) clearance K861016 for GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS, Substantially Equivalent on 1986-04-18. Applicant: Gamma Biologicals, Inc..

Clearance details

Applicant: Gamma Biologicals, Inc.
Product code: Code KTN
Advisory panel: Immunology
Date received: 1986-03-18
Decision date: 1986-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

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