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

Antigens, Histoplasma Capsulatum, All

21 CFR 866.3320 / Microbiology
FDA source (opens on fda.gov)

GMJ is the FDA product code for Antigens, Histoplasma Capsulatum, All, a class II device type, regulated under 21 CFR 866.3320. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
GMJ
Device name
Antigens, Histoplasma Capsulatum, All
Regulation
21 CFR 866.3320
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
12
Ingested recalls
2

Clearances, product code GMJ

By decision year
12 clearances under product code GMJ with a decision year between 1976 and 1983, 1980 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code GMJ by decision year
YearClearances
19762
19793
19805
19811
19831

Applicants with the most clearances

Product code GMJ
Applicants holding the most 510(k) clearances under product code GMJ
ApplicantClearances
IMMY, Inc.4
Meridian Diagnostics, Inc.4
I M, Inc.2
American Scientific Products1
Nolan Biological Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code