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

Antisera, Latex Agglutination, Cryptococcus Neoformans

21 CFR 866.3165 / Microbiology
FDA source (opens on fda.gov)

GMD is the FDA product code for Antisera, Latex Agglutination, Cryptococcus Neoformans, a class II device type, regulated under 21 CFR 866.3165. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
GMD
Device name
Antisera, Latex Agglutination, Cryptococcus Neoformans
Regulation
21 CFR 866.3165
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
10
Ingested recalls
3

Clearances, product code GMD

By decision year
10 clearances under product code GMD with a decision year between 1978 and 2012, 1981 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GMD by decision year
YearClearances
19781
19791
19801
19812
19891
19931
19941
20111
20121

Applicants with the most clearances

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

Companies listing this code with FDA

Companies whose registered establishments list this code