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

Name: FDA 510(k) clearance K861016
Creator: U.S. Food and Drug Administration
Published: 1986-04-18

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.. Device class: 2.

Clearance details

Applicant: Gamma Biologicals, Inc.
Product code: Code KTN
Device class: Class 2
Regulation: 21 CFR 866.5640
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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More clearances from Gamma Biologicals, Inc.

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K864207 — DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO1986-12-03
K832473 — GAMMA SLIDE TEST FOR PREGNANCY1983-08-16
K820647 — GAMMA FETAL BLEED SCREENING TEST1982-05-12
K813342 — GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION1982-03-04
K820072 — FE-CULT PLUS1982-03-04

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