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

Antigens, Ha, Treponema Pallidum

21 CFR 866.3830 / Microbiology
FDA source (opens on fda.gov)

GMT is the FDA product code for Antigens, Ha, Treponema Pallidum, a class II device type, regulated under 21 CFR 866.3830. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GMT
Device name
Antigens, Ha, Treponema Pallidum
Regulation
21 CFR 866.3830
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
9
Ingested recalls
0

Clearances, product code GMT

By decision year
9 clearances under product code GMT with a decision year between 1976 and 1997, 1991 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code GMT by decision year
YearClearances
19761
19792
19891
19901
19913
19971

Applicants with the most clearances

Product code GMT
Applicants holding the most 510(k) clearances under product code GMT
ApplicantClearances
Olympus Corp.2
Behring Diagnostics, Inc.1
Difco Laboratories, Inc.1
Fujirebio America, Inc.1
Fujirebio Diagnostics, Inc.1
Gamma Biologicals, Inc.1
Scimedx Tekfile Services1
Volu Sol Medical Industries1

Companies listing this code with FDA

Companies whose registered establishments list this code