Medical Device Manufacturer · US , Mchenry , IL

Armkel, LLC - FDA 510(k) Cleared Devices

68 submissions · 68 cleared · Since 1979
68
Total
68
Cleared
0
Denied

FDA 510(k) Regulatory Record - Armkel, LLC Microbiology

22 devices
1-22 of 22
Cleared Mar 03, 1997
LEGIONELLA IGG/IGM ELISA TEST SYSTEM
K963318 · LHL
Microbiology · 192d
Cleared Feb 24, 1997
CHLAMYDIA IGG ELISA TEST SYSTEM
K962558 · LJC
Microbiology · 238d
Cleared Feb 04, 1997
HERPES GROUP IGG ELISA TEST SYSTEM
K963645 · LGC
Microbiology · 145d
Cleared Jul 30, 1996
PYLORI IGG ELISA TEST SYSTEM
K961221 · LYR
Microbiology · 132d
Cleared Feb 07, 1989
BACTIGEN(R) MENINGITIDIS PANEL
K884965 · GWC
Microbiology · 69d
Cleared Feb 07, 1989
BACTIGEN(R) S. PNEUMONIAE
K884966 · GWC
Microbiology · 69d
Cleared Feb 07, 1989
BACTIGEN(R) H. INFLUENZAE TYPE B
K884967 · GRP
Microbiology · 69d
Cleared Feb 07, 1989
BACTIGEN(R) GROUP B STREPTOCOCCUS TEST
K885003 · GTZ
Microbiology · 68d
Cleared Feb 07, 1989
BACTIGEN(R) N. MENINGITIDIS
K885004 · GTJ
Microbiology · 68d
Cleared Oct 15, 1987
VIROGEN HSV ANTIBODY TEST
K871426 · GQO
Microbiology · 189d
Cleared Aug 27, 1987
BACTIGEN GROUP B STREPTOCOCCUS-CS TEST
K872114 · GTZ
Microbiology · 87d
Cleared Apr 22, 1987
BACTIGEN SALMONELLA-SHIGELLA TEST
K870813 · GRM
Microbiology · 50d
Cleared Nov 12, 1985
VIROGEN ROTATEST SLIDE TEST
K853399 · LIQ
Microbiology · 92d
Cleared Oct 17, 1985
VIROGEN HERPES SLIDE TEST
K852928 · GQO
Microbiology · 100d
Cleared May 29, 1985
BACTIGEN GROUP B STREPTOCOCCUS TEST
K850772 · GTZ
Microbiology · 93d
Cleared May 21, 1985
VIROGEN RUBELLA MICROTITER TEST
K844436 · LQN
Microbiology · 186d
Cleared May 20, 1985
VIROGEN RUBELLA SLIDE TEST
K844435 · LQN
Microbiology · 185d
Cleared Jul 06, 1984
BACTIGEN - N.MENNINIGITIDIS TEST
K841907 · GTJ
Microbiology · 59d
Cleared Sep 26, 1983
BACTIGEN S. PNEUMONIAE
K831887 · GWC
Microbiology · 105d
Cleared Mar 09, 1983
BACTIGEN-N. MENINGITIDIS
K823880 · GTJ
Microbiology · 72d
Cleared Oct 26, 1981
RHEUMATEX
K812882 · DHR
Microbiology · 12d
Cleared Apr 04, 1980
BACTOGEN-H. INFLUENZAE TYPE B
K800493 · GRO
Microbiology · 31d
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