Clinical Sciences, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
30
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K900688VARICELLA ZOSTER IGG CLIN-ELISA TEST KITMay 15, 1990
K883871EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590July 14, 1989
K883870EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590July 14, 1989
K891990RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600June 15, 1989
K883600EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550May 11, 1989
K883601EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550May 11, 1989
K874594TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560March 7, 1988
K872942IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530January 11, 1988
K860145RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540July 14, 1986
K860773TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560May 23, 1986
K854666CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530February 5, 1986
K852782HSVI - IGG ELISA-KITJanuary 21, 1986
K852781HSV2 - IGG ELISA-KITJanuary 21, 1986
K850158CHLAMYDIA FLUORO-KIT 1680March 21, 1985
K842541RAPID PLASMA REAGIN CARD TESTJuly 26, 1984
K833089CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT IIMay 2, 1984
K832675ANA MICROZYME TEST SYS #1610September 12, 1983
K830623INDIRECT FLUORO-KIT HSVJuly 7, 1983
K822911ANAZYME ANA PEROXIDASE TEST SYSTEMOctober 22, 1982
K822397ANA HEP-2 FLUORO-KITSeptember 21, 1982