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

Antiserum, Positive Control, Coccidioides Immitis

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

GMH is the FDA product code for Antiserum, Positive Control, Coccidioides Immitis, a class II device type, regulated under 21 CFR 866.3135. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GMH
Device name
Antiserum, Positive Control, 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
5
Ingested recalls
0

Clearances, product code GMH

By decision year
5 clearances under product code GMH with a decision year between 1976 and 1980, 1980 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code GMH by decision year
YearClearances
19761
19791
19803

Applicants with the most clearances

Product code GMH
Applicants holding the most 510(k) clearances under product code GMH
ApplicantClearances
Meridian Diagnostics, Inc.3
I M, Inc.1
IMMY, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code