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
GMAClass I

Antisera, Fluorescent, Sporothrix Schenekii

21 CFR 866.3680 / Microbiology
FDA source (opens on fda.gov)

GMA is the FDA product code for Antisera, Fluorescent, Sporothrix Schenekii, a class I device type, regulated under 21 CFR 866.3680. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
GMA
Device name
Antisera, Fluorescent, Sporothrix Schenekii
Regulation
21 CFR 866.3680
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 GMA

By decision year
1 clearance under product code GMA with a decision year between 1980 and 1980, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GMA by decision year
YearClearances
19801

Applicants with the most clearances

Product code GMA
Applicants holding the most 510(k) clearances under product code GMA
ApplicantClearances
IMMY, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code