Sealite Sciences, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Sealite Sciences, Inc.” (first 1994, latest 1997), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 63 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| CEP | Radioimmunoassay, Luteinizing Hormone | 2 | 2 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 2 | 2 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 | 1 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 1 | 1 |
| CFL | Radioimmunoassay, Human Growth Hormone | 1 | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | 1 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 | 1 |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
Review panels
- Clinical Chemistry (10)
- Immunology (1)
Most recent Sealite Sciences, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K974551 | SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY | CEC | 1997-12-22 | 18 |
| K972761 | SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY | CFL | 1997-09-25 | 63 |
| K970612 | SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY | DBF | 1997-06-24 | 126 |
| K970483 | AQUALITE INTACT PTH | CEW | 1997-04-14 | 63 |
| K970188 | SEALITE SCIENCES, INC. AQUALITE PROLACTIN | CFT | 1997-02-20 | 34 |
| K970085 | SEALITE SCIENCES AQUALITE FSH | CGJ | 1997-02-14 | 35 |
| K964925 | SEALITE SCIENCES, INC. AQUALITE LH | CEP | 1997-01-22 | 44 |
| K942661 | AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT | JLW | 1995-01-17 | 225 |
| K943437 | AQUALITE FSH | CGJ | 1994-12-28 | 163 |
| K943188 | SEALITE SCIENCE, INC. AQUALITE(R) LH | CEP | 1994-10-20 | 107 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sealite Sciences, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Sealite Sciences, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Sealite Sciences, Inc.” (first 1994, latest 1997), across 9 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sealite Sciences, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sealite Sciences, Inc. is 63 days.
Which FDA product codes appear under Sealite Sciences, Inc.?
The most frequent FDA product codes under this applicant name are CEP (Radioimmunoassay, Luteinizing Hormone, 2); CGJ (Radioimmunoassay, Follicle-Stimulating Hormone, 2); CEC (Radioimmunoassay, Free Thyroxine, 1).
Next steps
- See all 11 Sealite Sciences, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CEP, Sealite Sciences, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.