Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Clinical Sciences, Inc. — Predicate Candidate Screening
30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
261 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K900688 | VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT | Clinical Sciences, Inc. | 1990-05-15 | 91 | 1 |
| K883871 | EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590 | Clinical Sciences, Inc. | 1989-07-14 | 304 | 0 |
| K883870 | EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590 | Clinical Sciences, Inc. | 1989-07-14 | 304 | 0 |
| K891990 | RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600 | Clinical Sciences, Inc. | 1989-06-15 | 79 | 0 |
| K883601 | EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550 | Clinical Sciences, Inc. | 1989-05-11 | 261 | 0 |
| K883600 | EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550 | Clinical Sciences, Inc. | 1989-05-11 | 261 | 0 |
| K874594 | TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560 | Clinical Sciences, Inc. | 1988-03-07 | 119 | 0 |
| K872942 | IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 | Clinical Sciences, Inc. | 1988-01-11 | 168 | 0 |
| K860145 | RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540 | Clinical Sciences, Inc. | 1986-07-14 | 180 | 0 |
| K860773 | TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560 | Clinical Sciences, Inc. | 1986-05-23 | 81 | 0 |
| K854666 | CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530 | Clinical Sciences, Inc. | 1986-02-05 | 76 | 0 |
| K852782 | HSVI - IGG ELISA-KIT | Clinical Sciences, Inc. | 1986-01-21 | 204 | 0 |
| K852781 | HSV2 - IGG ELISA-KIT | Clinical Sciences, Inc. | 1986-01-21 | 204 | 0 |
| K850158 | CHLAMYDIA FLUORO-KIT 1680 | Clinical Sciences, Inc. | 1985-03-21 | 65 | 0 |
| K842541 | RAPID PLASMA REAGIN CARD TEST | Clinical Sciences, Inc. | 1984-07-26 | 24 | 0 |
| K833089 | CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II | Clinical Sciences, Inc. | 1984-05-02 | 233 | 0 |
| K832675 | ANA MICROZYME TEST SYS #1610 | Clinical Sciences, Inc. | 1983-09-12 | 34 | 0 |
| K830623 | INDIRECT FLUORO-KIT HSV | Clinical Sciences, Inc. | 1983-07-07 | 129 | 0 |
| K822911 | ANAZYME ANA PEROXIDASE TEST SYSTEM | Clinical Sciences, Inc. | 1982-10-22 | 21 | 0 |
| K822397 | ANA HEP-2 FLUORO-KIT | Clinical Sciences, Inc. | 1982-09-21 | 42 | 2 |
| K801876 | STREP B POLYVALENT FLUORO-KIT | Clinical Sciences, Inc. | 1980-09-16 | 42 | 0 |
| K800328 | NEISSERIA GONORRHOEAE FLUORO-KIT | Clinical Sciences, Inc. | 1980-03-03 | 20 | 0 |
| K800228 | IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT | Clinical Sciences, Inc. | 1980-02-21 | 16 | 0 |
| K800229 | IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT | Clinical Sciences, Inc. | 1980-02-21 | 16 | 0 |
| K791749 | INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL | Clinical Sciences, Inc. | 1979-10-17 | 37 | 0 |
| K791827 | LDH CLINI GEL KIT | Clinical Sciences, Inc. | 1979-10-01 | 14 | 0 |
| K791826 | CPK CLINI GEL KIT | Clinical Sciences, Inc. | 1979-10-01 | 14 | 0 |
| K791447 | MARTIN LEWIS AGAR CSI 3169 | Clinical Sciences, Inc. | 1979-09-17 | 48 | 0 |
| K791446 | MARTIN LEWIS JEMBEC CSI 8872 | Clinical Sciences, Inc. | 1979-09-17 | 48 | 0 |
| K770057 | NDNA IMMUNOPATH FLUORO-KIT | Clinical Sciences, Inc. | 1977-04-05 | 84 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda