Clinical Sciences, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 30
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K900688 | VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT | May 15, 1990 |
| K883871 | EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590 | July 14, 1989 |
| K883870 | EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590 | July 14, 1989 |
| K891990 | RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600 | June 15, 1989 |
| K883600 | EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550 | May 11, 1989 |
| K883601 | EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550 | May 11, 1989 |
| K874594 | TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560 | March 7, 1988 |
| K872942 | IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 | January 11, 1988 |
| K860145 | RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540 | July 14, 1986 |
| K860773 | TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560 | May 23, 1986 |
| K854666 | CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530 | February 5, 1986 |
| K852782 | HSVI - IGG ELISA-KIT | January 21, 1986 |
| K852781 | HSV2 - IGG ELISA-KIT | January 21, 1986 |
| K850158 | CHLAMYDIA FLUORO-KIT 1680 | March 21, 1985 |
| K842541 | RAPID PLASMA REAGIN CARD TEST | July 26, 1984 |
| K833089 | CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II | May 2, 1984 |
| K832675 | ANA MICROZYME TEST SYS #1610 | September 12, 1983 |
| K830623 | INDIRECT FLUORO-KIT HSV | July 7, 1983 |
| K822911 | ANAZYME ANA PEROXIDASE TEST SYSTEM | October 22, 1982 |
| K822397 | ANA HEP-2 FLUORO-KIT | September 21, 1982 |