510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K822663Substantially Equivalent

Febrile Antigen Kit

Oxoid U.S.A., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822663 is the FDA 510(k) clearance record for FEBRILE ANTIGEN KIT, a class II device, cleared for Oxoid U.S.A., Inc. on under FDA product code GSO (Antigens (Febrile), Agglutination, Brucella Spp.). FDA records list 93 510(k) clearances for Oxoid U.S.A., Inc., from to . As of , FDA records show no recalls naming K822663.

Clearance record

Decision date
Received
(18 days to decision)
Product code
GSO Antigens (Febrile), Agglutination, Brucella Spp.
Regulation
21 CFR 866.3085
Device class
Class II
Review panel
Microbiology
Applicant
Oxoid U.S.A., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GSO

Trailing 12 months

FDA records hold no clearances under product code GSO in the trailing twelve months.

FDA records show no clearances under product code GSO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GSO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260