FE-CULT PLUS— 510(k) K820072

Substantially Equivalent

Gamma Biologicals, Inc.

FDA 510(k) clearance K820072 for FE-CULT PLUS, Substantially Equivalent on 1982-03-04. Applicant: Gamma Biologicals, Inc.. Device class: 2.

Clearance details

Applicant: Gamma Biologicals, Inc.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 1982-01-12
Decision date: 1982-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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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.