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

Antigens (Febrile), Agglutination, Brucella Spp.

21 CFR 866.3085 / Microbiology
FDA source (opens on fda.gov)

GSO is the FDA product code for Antigens (Febrile), Agglutination, Brucella Spp., a class II device type, regulated under 21 CFR 866.3085. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
GSO
Device name
Antigens (Febrile), Agglutination, Brucella Spp.
Regulation
21 CFR 866.3085
Device class
Class II
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
12
Ingested recalls
2

Clearances, product code GSO

By decision year
12 clearances under product code GSO with a decision year between 1979 and 1997, 1995 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code GSO by decision year
YearClearances
19791
19821
19891
19957
19972

Applicants with the most clearances

Product code GSO
Applicants holding the most 510(k) clearances under product code GSO
ApplicantClearances
SA Scientific, Ltd7
Lee Laboratories, Inc.2
Investigacion Farmaceutica S.A. de C.V.1
Oxoid U.S.A., Inc.1
Volu Sol Medical Industries1

Companies listing this code with FDA

Companies whose registered establishments list this code