Company ยท US
Clinical Sciences, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1990. Name variants (Inc, Corp, punctuation) are merged.
30510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DAA | Igg, Peroxidase, Antigen, Antiserum, Control | 3 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 |
| GQO | Antisera, Cf, Herpesvirus Hominis 1,2 | 2 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 2 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 |
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | 2 |
| LSE | Epstein-Barr Virus, Other | 2 |
| CFE | Electrophoretic, Lactate Dehydrogenase Isoenzymes | 1 |
| DBE | Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| GMQ | Antigens, Nontreponemal, All | 1 |
| GQH | Antigen, Cf (Including Cf Control), Cytomegalovirus | 1 |
| GQI | Antiserum, Cf, Cytomegalovirus | 1 |
| GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 | 1 |
| GTH | Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae | 1 |
| GTX | Antisera, Fluorescent, All Groups, Streptococcus Spp. | 1 |
| JHT | Chromatographic Separation, Cpk Isoenzymes | 1 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 1 |
| LFY | Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster | 1 |
| LJB | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 15, 1990 | K900688 | VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT Clinical Sciences, Inc. | LFY |
| Jul 14, 1989 | K883871 | EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590 Clinical Sciences, Inc. | LSE |
| Jul 14, 1989 | K883870 | EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590 Clinical Sciences, Inc. | LSE |
| Jun 15, 1989 | K891990 | RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600 Clinical Sciences, Inc. | LJB |
| May 11, 1989 | K883601 | EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550 Clinical Sciences, Inc. | LLM |
| May 11, 1989 | K883600 | EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550 Clinical Sciences, Inc. | LLM |
| Mar 7, 1988 | K874594 | TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560 Clinical Sciences, Inc. | LGD |
| Jan 11, 1988 | K872942 | IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 Clinical Sciences, Inc. | LKQ |
| Jul 14, 1986 | K860145 | RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540 Clinical Sciences, Inc. | LFX |
| May 23, 1986 | K860773 | TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560 Clinical Sciences, Inc. | LGD |
| Feb 5, 1986 | K854666 | CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530 Clinical Sciences, Inc. | GQI |
| Jan 21, 1986 | K852782 | HSVI - IGG ELISA-KIT Clinical Sciences, Inc. | GQO |
| Jan 21, 1986 | K852781 | HSV2 - IGG ELISA-KIT Clinical Sciences, Inc. | GQO |
| Mar 21, 1985 | K850158 | CHLAMYDIA FLUORO-KIT 1680 Clinical Sciences, Inc. | LJP |
| Jul 26, 1984 | K842541 | RAPID PLASMA REAGIN CARD TEST Clinical Sciences, Inc. | GMQ |
| May 2, 1984 | K833089 | CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II Clinical Sciences, Inc. | GQH |
| Sep 12, 1983 | K832675 | ANA MICROZYME TEST SYS #1610 Clinical Sciences, Inc. | DAA |
| Jul 7, 1983 | K830623 | INDIRECT FLUORO-KIT HSV Clinical Sciences, Inc. | GQL |
| Oct 22, 1982 | K822911 | ANAZYME ANA PEROXIDASE TEST SYSTEM Clinical Sciences, Inc. | DAA |
| Sep 21, 1982 | K822397 | ANA HEP-2 FLUORO-KIT Clinical Sciences, Inc. | DHN |
| Sep 16, 1980 | K801876 | STREP B POLYVALENT FLUORO-KIT Clinical Sciences, Inc. | GTX |
| Mar 3, 1980 | K800328 | NEISSERIA GONORRHOEAE FLUORO-KIT Clinical Sciences, Inc. | GTH |
| Feb 21, 1980 | K800229 | IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT Clinical Sciences, Inc. | DBM |
| Feb 21, 1980 | K800228 | IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT Clinical Sciences, Inc. | DBE |
| Oct 17, 1979 | K791749 | INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL Clinical Sciences, Inc. | DAA |
| Oct 1, 1979 | K791827 | LDH CLINI GEL KIT Clinical Sciences, Inc. | CFE |
| Oct 1, 1979 | K791826 | CPK CLINI GEL KIT Clinical Sciences, Inc. | JHT |
| Sep 17, 1979 | K791447 | MARTIN LEWIS AGAR CSI 3169 Clinical Sciences, Inc. | JTY |
| Sep 17, 1979 | K791446 | MARTIN LEWIS JEMBEC CSI 8872 Clinical Sciences, Inc. | JTY |
| Apr 5, 1977 | K770057 | NDNA IMMUNOPATH FLUORO-KIT Clinical Sciences, Inc. | DHN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||