GAMMA SLIDE TEST FOR PREGNANCY— 510(k) K832473

Name: FDA 510(k) clearance K832473
Creator: U.S. Food and Drug Administration
Published: 1983-08-16

Substantially Equivalent

Gamma Biologicals, Inc.

FDA 510(k) clearance K832473 for GAMMA SLIDE TEST FOR PREGNANCY, Substantially Equivalent on 1983-08-16. Applicant: Gamma Biologicals, Inc.. Device class: 2.

Clearance details

Applicant: Gamma Biologicals, Inc.
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1983-07-26
Decision date: 1983-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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