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

Antisera, Hai (Including Hai Control), Rubella

21 CFR 866.3510 / Microbiology
FDA source (opens on fda.gov)

GOK is the FDA product code for Antisera, Hai (Including Hai Control), Rubella, a class II device type, regulated under 21 CFR 866.3510. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GOK
Device name
Antisera, Hai (Including Hai Control), Rubella
Regulation
21 CFR 866.3510
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
11
Ingested recalls
0

Clearances, product code GOK

By decision year
11 clearances under product code GOK with a decision year between 1977 and 1983, 1978 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code GOK by decision year
YearClearances
19772
19784
19791
19802
19811
19831

Applicants with the most clearances

Product code GOK
Applicants holding the most 510(k) clearances under product code GOK
ApplicantClearances
Flow Laboratories, Inc.2
Microbiological Assoc.2
Organon LLC2
Abbott Medical1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Electro-Nucleonics Laboratories, Inc.1
Northeast Biomedical Labs., Inc.1
Ortho Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code