GMT · Class II · 21 CFR 866.3830

FDA Product Code GMT: Antigens, Ha, Treponema Pallidum

Leading manufacturers include Olympus Corp., Gamma Biologicals, Inc. and Volu Sol Medical Industries.

9
Total
9
Cleared
121d
Avg days
1976
Since

FDA 510(k) Cleared Antigens, Ha, Treponema Pallidum Devices (Product Code GMT)

9 devices
1–9 of 9
Cleared Nov 13, 1997
SERODIA TP-PA
K971502
Scimedx Tekfile Services
Microbiology · 203d
Cleared Jul 24, 1991
OLYMPUS PK TP(TM) SYSTEM, MODIFICATION
K911640
Olympus Corp.
Microbiology · 107d
Cleared May 07, 1991
MODIFIED PK TP CONTROL
K911266
Olympus Corp.
Microbiology · 53d
Cleared May 15, 1990
CELLOGNOST SYPHILIS H
K896410
Behring Diagnostics, Inc.
Microbiology · 189d
Cleared Nov 17, 1989
OLYMPUS PK(TM) TP
K893124
Fujirebio Diagnostics,Inc.
Microbiology · 206d
Cleared Nov 13, 1979
BACTO-HATTS
K791897
Difco Laboratories, Inc.
Microbiology · 49d
Cleared Sep 24, 1979
AGGLUTINOTEST-SYPHILIS
K791457
Volu Sol Medical Industries
Microbiology · 49d
Cleared Aug 03, 1976
REAGENT, VDRL
K760098
Gamma Biologicals, Inc.
Microbiology · 50d

About Product Code GMT - Regulatory Context