FEBRILE ANTIGEN KIT— 510(k) K822663

Substantially Equivalent

Oxoid U.S.A., Inc.

FDA 510(k) clearance K822663 for FEBRILE ANTIGEN KIT, Substantially Equivalent on 1982-09-21. Applicant: Oxoid U.S.A., Inc.. Device class: 2.

Clearance details

Applicant: Oxoid U.S.A., Inc.
Product code: Code GSO
Device class: Class 2
Regulation: 21 CFR 866.3085
Advisory panel: Microbiology
Date received: 1982-09-03
Decision date: 1982-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K874303 — STAPHYLASE TEST1987-11-06
K872956 — SORBITOL MACCONKEY AGAR NO. 3 CM 8131987-08-10

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