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

Antigens, Ha (Including Ha Control), Adenovirus 1-33

21 CFR 866.3020 / Microbiology
FDA source (opens on fda.gov)

GOB is the FDA product code for Antigens, Ha (Including Ha Control), Adenovirus 1-33, a class I device type, regulated under 21 CFR 866.3020. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
GOB
Device name
Antigens, Ha (Including Ha Control), Adenovirus 1-33
Regulation
21 CFR 866.3020
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 GOB

By decision year
1 clearance under product code GOB with a decision year between 1987 and 1987, 1987 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GOB by decision year
YearClearances
19871

Applicants with the most clearances

Product code GOB
Applicants holding the most 510(k) clearances under product code GOB
ApplicantClearances
Mercia Diagnostics, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code