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

Antigen, Cf And / Or Id, Coccidioides Immitis

21 CFR 866.3135 / Microbiology
FDA source (opens on fda.gov)

GMI is the FDA product code for Antigen, Cf And / Or Id, Coccidioides Immitis, a class II device type, regulated under 21 CFR 866.3135. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
GMI
Device name
Antigen, Cf And / Or Id, Coccidioides Immitis
Regulation
21 CFR 866.3135
Device class
Class II
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
11
Ingested recalls
1

Clearances, product code GMI

By decision year
11 clearances under product code GMI with a decision year between 1978 and 1989, 1980 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code GMI by decision year
YearClearances
19781
19792
19805
19812
19891

Applicants with the most clearances

Product code GMI
Applicants holding the most 510(k) clearances under product code GMI
ApplicantClearances
Meridian Diagnostics, Inc.4
American Scientific Products2
IMMY, Inc.2
I M, Inc.1
Nolan Biological Laboratories, Inc.1
Schiff & Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code