Clinical Sciences, Inc.: FDA clearances and approvals
Clinical Sciences, Inc. has 30 FDA 510(k) clearances (first 1977, latest 1990), across 22 product codes in 4 review panels. Median 510(k) review time: 78 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DAA | Igg, Peroxidase, Antigen, Antiserum, Control | 3 | 3 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | 2 |
| GQO | Antisera, Cf, Herpesvirus Hominis 1,2 | 2 | 2 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 2 | 2 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | 2 |
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | 2 | 2 |
| LSE | Epstein-Barr Virus, Other | 2 | 2 |
| CFE | Electrophoretic, Lactate Dehydrogenase Isoenzymes | 1 | 1 |
| DBE | Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
Plus 12 more product codes.
Review panels
- Microbiology (21)
- Immunology (4)
- Pathology (3)
- Clinical Chemistry (2)
Most recent Clinical Sciences, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K900688 | VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT | LFY | 1990-05-15 | 91 |
| K883871 | EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590 | LSE | 1989-07-14 | 304 |
| K883870 | EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590 | LSE | 1989-07-14 | 304 |
| K891990 | RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600 | LJB | 1989-06-15 | 79 |
| K883601 | EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550 | LLM | 1989-05-11 | 261 |
| K883600 | EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550 | LLM | 1989-05-11 | 261 |
| K874594 | TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560 | LGD | 1988-03-07 | 119 |
| K872942 | IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 | LKQ | 1988-01-11 | 168 |
| K860145 | RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540 | LFX | 1986-07-14 | 180 |
| K860773 | TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560 | LGD | 1986-05-23 | 81 |
20 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Clinical Sciences, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Clinical Sciences, Inc. have?
Clinical Sciences, Inc. has 30 FDA 510(k) clearances (first 1977, latest 1990), across 22 product codes in 4 review panels.
How long does FDA take to clear Clinical Sciences, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Clinical Sciences, Inc.'s cleared 510(k)s is 78 days.
What devices does Clinical Sciences, Inc. make?
Its most frequent FDA product codes are DAA (Igg, Peroxidase, Antigen, Antiserum, Control, 3); DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, 2); GQO (Antisera, Cf, Herpesvirus Hominis 1,2, 2).
Has Clinical Sciences, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Clinical Sciences, Inc. Related entities may recall under other names.
Next steps
- See all 30 Clinical Sciences, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DAA, Clinical Sciences, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.