GTJ · Class II · 21 CFR 866.3390

FDA Product Code GTJ: Antisera, All Groups, N. Meningitidis

Leading manufacturers include Armkel, LLC, Bd Becton Dickinson Vacutainer Systems Preanalytic and Pharmacia, Inc..

16
Total
16
Cleared
118d
Avg days
1977
Since

FDA 510(k) Cleared Antisera, All Groups, N. Meningitidis Devices (Product Code GTJ)

16 devices
1–16 of 16
Cleared May 30, 1996
DIRECTIGEN MENINGITIS COMBO TEST
K952791
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 346d
Cleared Mar 23, 1992
DIRECTIGEN MENINGITIS COMBO TEST KIT
K915330
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 118d
Cleared Aug 12, 1991
SLIDEX MENINGITE-KIT 5
K910210
Vitek Systems, Inc.
Microbiology · 209d
Cleared Feb 07, 1989
BACTIGEN(R) N. MENINGITIDIS
K885004
Armkel, LLC
Microbiology · 68d
Cleared Oct 17, 1985
PHADEBACT CSF TEST
K844999
Pharmacia, Inc.
Chemistry · 295d
Cleared Jan 25, 1985
DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST
K844407
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 73d
Cleared Jul 06, 1984
BACTIGEN - N.MENNINIGITIDIS TEST
K841907
Armkel, LLC
Microbiology · 59d
Cleared Mar 09, 1983
BACTIGEN-N. MENINGITIDIS
K823880
Armkel, LLC
Microbiology · 72d
Cleared Dec 30, 1982
PHADEBACT CSF TEST 20
K822810
Pharmacia, Inc.
Immunology · 101d

About Product Code GTJ - Regulatory Context