GWC · Class I · 21 CFR 866.3740

FDA Product Code GWC: Antisera, All Types, Streptococcus Pneumoniae

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

9
Total
9
Cleared
65d
Avg days
1980
Since

FDA 510(k) Cleared Antisera, All Types, Streptococcus Pneumoniae Devices (Product Code GWC)

9 devices
1–9 of 9
Cleared Feb 07, 1989
BACTIGEN(R) MENINGITIDIS PANEL
K884965
Armkel, LLC
Microbiology · 69d
Cleared Feb 07, 1989
BACTIGEN(R) S. PNEUMONIAE
K884966
Armkel, LLC
Microbiology · 69d
Cleared Dec 18, 1986
LKB ULTROBACT (TM) PNEUMOCOCCUS KIT
K862848
Lkb Instruments, Inc.
Microbiology · 142d
Cleared Jul 02, 1984
VENTRESCREEN STREP A TEST
K842239
Ventrex Laboratories, Inc.
Microbiology · 27d
Cleared May 02, 1984
WELLCOGEN S. PNEUMONIAE
K841376
Wellcome Diagnostics
Microbiology · 29d
Cleared Sep 26, 1983
BACTIGEN S. PNEUMONIAE
K831887
Armkel, LLC
Microbiology · 105d
Cleared Jul 30, 1982
BBL PNEUMOSLIDE TEST
K821960
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 29d
Cleared Oct 31, 1980
PHADEBACT PNEUMOCOCCUS TEST
K802337
Pharmacia, Inc.
Microbiology · 35d

About Product Code GWC - Regulatory Context