Armkel, LLC - FDA 510(k) Cleared Devices
68
Total
68
Cleared
0
Denied
68 devices
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
Dec 20, 1988
MODIFICATION OF MONO-PLUS(TM)
Immunology
112d
Cleared
Oct 15, 1987
VIROGEN HSV ANTIBODY TEST
Microbiology
189d
Cleared
Oct 02, 1987
ANSWER OVULATION TEST KIT
Chemistry
189d
Cleared
Aug 27, 1987
BACTIGEN GROUP B STREPTOCOCCUS-CS TEST
Microbiology
87d
Cleared
Apr 22, 1987
BACTIGEN SALMONELLA-SHIGELLA TEST
Microbiology
50d
Cleared
Sep 29, 1986
PREGNASLIDE
Chemistry
41d
Cleared
Jul 03, 1986
MONO-LATEX (TM) SLIDE TEST
Immunology
37d
Cleared
Apr 11, 1986
ANSWER PLUS AT HOME PREGNANCY TEST
Chemistry
91d
Cleared
Mar 04, 1986
RIGIDENT CREAM
Dental
119d
Cleared
Nov 12, 1985
VIROGEN ROTATEST SLIDE TEST
Microbiology
92d
Cleared
Oct 17, 1985
VIROGEN HERPES SLIDE TEST
Microbiology
100d
Cleared
Jun 28, 1985
ANSWER
Chemistry
30d
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
May 01, 1985
PREGNA-ZYME
Chemistry
51d
Cleared
Sep 14, 1984
ANSWER ONE-DAY
Chemistry
23d
Cleared
Jul 06, 1984
BACTIGEN - N.MENNINIGITIDIS TEST
Microbiology
59d
Cleared
Sep 26, 1983
BACTIGEN S. PNEUMONIAE
Microbiology
105d
Cleared
Aug 11, 1983
UCG-BETA SLIDE MONOCLONAL
Chemistry
70d