Cambridge Bioscience Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Cambridge Bioscience Corp.” (first 1985, latest 1989), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 113 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 |
|---|---|---|---|
| GOD | Antigens, Cf (Including Cf Control), Adenovirus 1-33 | 3 | 3 |
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | 1 | 1 |
| LSR | Reagent, Borrelia Serological Reagent | 1 | 1 |
Review panels
- Microbiology (5)
Most recent Cambridge Bioscience Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K890281 | HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES | LSR | 1989-03-15 | 57 |
| K881894 | ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48) | GOD | 1988-07-08 | 64 |
| K873312 | ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST | GOD | 1988-02-24 | 190 |
| K873082 | ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST | GOD | 1988-02-24 | 203 |
| K852969 | ROTACLONE ROTAVIRUS DIAGNOSTIC KIT | LIQ | 1985-11-05 | 113 |
Recalls
openFDA lists no recalls under a recalling firm named Cambridge Bioscience Corp..
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.
- Cambridge Heart, Inc. (17 510(k)s)
- Cambridge Medical Technology (14 510(k)s)
- Cambridge Instruments, Inc. (13 510(k)s)
- Cambridge Medical Instruments, Inc. (8 510(k)s)
- Cambridge Nuclear Corp. (5 510(k)s)
- Cambridge Chemical Products, Inc. (4 510(k)s)
- Cambridge Diagnostics Ireland, Ltd. (4 510(k)s)
- Cambridge Life Sciences Plc. (4 510(k)s)
- Cambridge Biotech Corp. (3 510(k)s)
- Cambridge Sensors Limited (3 510(k)s)
- Cambridge Scientific, Inc. (2 510(k)s)
- Cambridge Technologies, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cambridge Bioscience Corp.?
FDA lists 5 510(k) clearances under the applicant name “Cambridge Bioscience Corp.” (first 1985, latest 1989), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cambridge Bioscience Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cambridge Bioscience Corp. is 113 days.
Which FDA product codes appear under Cambridge Bioscience Corp.?
The most frequent FDA product codes under this applicant name are GOD (Antigens, Cf (Including Cf Control), Adenovirus 1-33, 3); LIQ (Enzyme Linked Immunoabsorbent Assay, Rotavirus, 1); LSR (Reagent, Borrelia Serological Reagent, 1).
Next steps
- See all 5 Cambridge Bioscience Corp. clearances with predicates and recalls
- Run predicate analysis for product code GOD, Cambridge Bioscience Corp.'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.