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
GMNClass II

Antigens, Cf, Toxoplasma Gondii

21 CFR 866.3780 / Microbiology
FDA source (opens on fda.gov)

GMN is the FDA product code for Antigens, Cf, Toxoplasma Gondii, a class II device type, regulated under 21 CFR 866.3780. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GMN
Device name
Antigens, Cf, Toxoplasma Gondii
Regulation
21 CFR 866.3780
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
3
Ingested recalls
0

Clearances, product code GMN

By decision year
3 clearances under product code GMN with a decision year between 1979 and 1989, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GMN by decision year
YearClearances
19791
19871
19891

Applicants with the most clearances

Product code GMN
Applicants holding the most 510(k) clearances under product code GMN
ApplicantClearances
Microbix Biosystems, Inc.1
Virion (U.S.), Inc.1
Volu Sol Medical Industries1

Companies listing this code with FDA

Companies whose registered establishments list this code

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