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

Antigen, B. Pertussis

21 CFR 866.3065 / Microbiology
FDA source (opens on fda.gov)

GOX is the FDA product code for Antigen, B. Pertussis, a class I device type, regulated under 21 CFR 866.3065. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
GOX
Device name
Antigen, B. Pertussis
Regulation
21 CFR 866.3065
Device class
Class I
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
1
Ingested recalls
0

Clearances, product code GOX

By decision year
1 clearance under product code GOX with a decision year between 1979 and 1979, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GOX by decision year
YearClearances
19791

Applicants with the most clearances

Product code GOX
Applicants holding the most 510(k) clearances under product code GOX
ApplicantClearances
Volu Sol Medical Industries1

Companies listing this code with FDA

Companies whose registered establishments list this code