510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972394Substantially Equivalent

Vista Antigen Brucella Abortus

Lee Laboratories, Inc., Grayson GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972394 is the FDA 510(k) clearance record for VISTA ANTIGEN BRUCELLA ABORTUS, a class II device, cleared for Lee Laboratories, Inc. on under FDA product code GSO (Antigens (Febrile), Agglutination, Brucella Spp.). FDA records list 16 510(k) clearances for Lee Laboratories, Inc., from to . As of , FDA records show no recalls naming K972394.

Clearance record

Decision date
Received
(60 days to decision)
Product code
GSO Antigens (Febrile), Agglutination, Brucella Spp.
Regulation
21 CFR 866.3085
Device class
Class II
Review panel
Microbiology
Applicant
Lee Laboratories, Inc. 1475 Hwy. 78, SW, Grayson GA
510(k) summary
Statement
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