Boots-Celltech Diagnostics, Inc. - FDA 510(k) Cleared Devices
20
Total
20
Cleared
0
Denied
FDA 510(k) Regulatory Record - Boots-Celltech Diagnostics, Inc. Microbiology ✕
11 devices
Cleared
Nov 17, 1989
IDEIA HERPES SIMPLEX VIRUS TEST
Microbiology
918d
Cleared
Dec 08, 1988
MODIFIED IDEIA CHLAMYDIA TEST
Microbiology
283d
Cleared
Feb 24, 1988
IMAGEN INFLUENZA VIRUS A AND B TESTMI
Microbiology
210d
Cleared
Jun 15, 1987
MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST
Microbiology
18d
Cleared
May 08, 1987
IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST
Microbiology
86d
Cleared
Apr 20, 1987
IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT
Microbiology
119d
Cleared
Mar 12, 1987
MODIFIED IMAGEN(TM) CHLAMYDIA TEST
Microbiology
113d
Cleared
Aug 19, 1986
MODIFIED IDEIA CHLAMYDIA TEST
Microbiology
91d
Cleared
Aug 04, 1986
IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT
Microbiology
27d
Cleared
Jan 03, 1986
IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST
Microbiology
88d
Cleared
Feb 06, 1985
IMAGEN CHLAMYDIA TEST
Microbiology
68d