Ocean Scientific, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Ocean Scientific, Inc.” (first 1984, latest 1989), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 54 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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 3 | 3 |
| GMQ | Antigens, Nontreponemal, All | 1 | 1 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 | 1 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 1 | 1 |
Review panels
- Clinical Chemistry (5)
- Microbiology (1)
Most recent Ocean Scientific, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K893810 | IMMUNO-WASH AUTOMATED TUBE WASHER | JQW | 1989-08-03 | 73 |
| K873638 | MICRO-CHEM ANALYZER | JJQ | 1987-09-29 | 20 |
| K864731 | OCEAN SCIENTIFIC VDRL TEST | GMQ | 1987-03-10 | 96 |
| K863976 | OCEAN SCIENTIFIC VACUTEST | JKA | 1986-10-24 | 10 |
| K860987 | MINI-CHEM ANALYZER | JJQ | 1986-05-05 | 49 |
| K840340 | CHEM-STAT ANALYZER | JJQ | 1984-03-23 | 58 |
Recalls
openFDA lists no recalls under a recalling firm named Ocean Scientific, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Ocean Medical Products, Ltd. (9 510(k)s)
- Ocean Optical Co., Inc. (1 510(k)s)
- Ocean Pacific Med Tec (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ocean Scientific, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Ocean Scientific, Inc.” (first 1984, latest 1989), across 4 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 Ocean Scientific, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ocean Scientific, Inc. is 54 days.
Which FDA product codes appear under Ocean Scientific, Inc.?
The most frequent FDA product codes under this applicant name are JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use, 3); GMQ (Antigens, Nontreponemal, All, 1); JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 1).
Next steps
- See all 6 Ocean Scientific, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJQ, Ocean Scientific, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.