REAGENT, VDRL— 510(k) K760098

Substantially Equivalent

Gamma Biologicals, Inc.

FDA 510(k) clearance K760098 for REAGENT, VDRL, Substantially Equivalent on 1976-08-03. Applicant: Gamma Biologicals, Inc.. Device class: 2.

Clearance details

Applicant: Gamma Biologicals, Inc.
Product code: Code GMT
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1976-06-14
Decision date: 1976-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code GMT

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K896410 — CELLOGNOST SYPHILIS H1990-05-15

More clearances from Gamma Biologicals, Inc.

K864207 — DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO1986-12-03
K861016 — GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS1986-04-18
K832473 — GAMMA SLIDE TEST FOR PREGNANCY1983-08-16
K820647 — GAMMA FETAL BLEED SCREENING TEST1982-05-12
K813342 — GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION1982-03-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.