Armkel, LLC - FDA 510(k) Cleared Devices
68
Total
68
Cleared
0
Denied
FDA 510(k) Regulatory Record - Armkel, LLC Microbiology ✕
22 devices
Cleared
Mar 03, 1997
LEGIONELLA IGG/IGM ELISA TEST SYSTEM
Microbiology
192d
Cleared
Feb 24, 1997
CHLAMYDIA IGG ELISA TEST SYSTEM
Microbiology
238d
Cleared
Feb 04, 1997
HERPES GROUP IGG ELISA TEST SYSTEM
Microbiology
145d
Cleared
Jul 30, 1996
PYLORI IGG ELISA TEST SYSTEM
Microbiology
132d
Cleared
Feb 07, 1989
BACTIGEN(R) MENINGITIDIS PANEL
Microbiology
69d
Cleared
Feb 07, 1989
BACTIGEN(R) S. PNEUMONIAE
Microbiology
69d
Cleared
Feb 07, 1989
BACTIGEN(R) H. INFLUENZAE TYPE B
Microbiology
69d
Cleared
Feb 07, 1989
BACTIGEN(R) GROUP B STREPTOCOCCUS TEST
Microbiology
68d
Cleared
Feb 07, 1989
BACTIGEN(R) N. MENINGITIDIS
Microbiology
68d
Cleared
Oct 15, 1987
VIROGEN HSV ANTIBODY TEST
Microbiology
189d
Cleared
Aug 27, 1987
BACTIGEN GROUP B STREPTOCOCCUS-CS TEST
Microbiology
87d
Cleared
Apr 22, 1987
BACTIGEN SALMONELLA-SHIGELLA TEST
Microbiology
50d
Cleared
Nov 12, 1985
VIROGEN ROTATEST SLIDE TEST
Microbiology
92d
Cleared
Oct 17, 1985
VIROGEN HERPES SLIDE TEST
Microbiology
100d
Cleared
May 29, 1985
BACTIGEN GROUP B STREPTOCOCCUS TEST
Microbiology
93d
Cleared
May 21, 1985
VIROGEN RUBELLA MICROTITER TEST
Microbiology
186d
Cleared
May 20, 1985
VIROGEN RUBELLA SLIDE TEST
Microbiology
185d
Cleared
Jul 06, 1984
BACTIGEN - N.MENNINIGITIDIS TEST
Microbiology
59d
Cleared
Sep 26, 1983
BACTIGEN S. PNEUMONIAE
Microbiology
105d
Cleared
Mar 09, 1983
BACTIGEN-N. MENINGITIDIS
Microbiology
72d
Cleared
Oct 26, 1981
RHEUMATEX
Microbiology
12d
Cleared
Apr 04, 1980
BACTOGEN-H. INFLUENZAE TYPE B
Microbiology
31d