510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
GOMClass II

Antisera, Cf, Rubella

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

GOM is the FDA product code for Antisera, Cf, Rubella, a class II device type, regulated under 21 CFR 866.3510. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GOM
Device name
Antisera, Cf, 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
2
Ingested recalls
0

Clearances, product code GOM

By decision year
2 clearances under product code GOM with a decision year between 1995 and 1995, 1995 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GOM by decision year
YearClearances
19952

Applicants with the most clearances

Product code GOM
Applicants holding the most 510(k) clearances under product code GOM
ApplicantClearances
Pyramid Biological Corp.2

Companies listing this code with FDA

Companies whose registered establishments list this code