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
GONClass II

Antigen, Cf (Including Cf Control), Rubella

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

GON is the FDA product code for Antigen, Cf (Including Cf Control), Rubella, a class II device type, regulated under 21 CFR 866.3510. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GON
Device name
Antigen, Cf (Including Cf 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
5
Ingested recalls
0

Clearances, product code GON

By decision year
5 clearances under product code GON with a decision year between 1978 and 1989, 1980 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GON by decision year
YearClearances
19781
19802
19881
19891

Applicants with the most clearances

Product code GON
Applicants holding the most 510(k) clearances under product code GON
ApplicantClearances
Orion Diagnostica, Inc.2
Microbiological Assoc.1
Microbix Biosystems, Inc.1
Syva Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code GON.