Cambridge Medical Technology: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Cambridge Medical Technology” (first 1982, latest 1989), across 12 product codes in 2 review panels. Median 510(k) review time under this name: 37 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 |
|---|---|---|---|
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 2 | 2 |
| CGR | Radioimmunoassay, Cortisol | 2 | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 1 | 1 |
| CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | 1 |
| DPB | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep. | 1 | 1 |
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 1 | 1 |
| JLS | Radioimmunoassay, Progesterone | 1 | 1 |
| JMG | Radioimmunoassay (Two-Site Solid Phase), Ferritin | 1 | 1 |
Plus 2 more product codes.
Review panels
Most recent Cambridge Medical Technology 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K890837 | RIA-GNOST INSULIN | CFP | 1989-04-26 | 64 |
| K890836 | RIA-GNOST PROGESTERONE | JLS | 1989-03-16 | 23 |
| K890697 | RIA-GNOST FERRITIN | JMG | 1989-03-16 | 34 |
| K873737 | NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY | CDP | 1987-11-24 | 70 |
| K870573 | T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT | CDX | 1987-04-22 | 71 |
| K862871 | RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL | CGR | 1986-08-19 | 21 |
| K860130 | TESTOSTERONE COATED TUBES RADIOIMMUNOASSAY KIT | CDZ | 1986-02-19 | 36 |
| K855169 | T3 UPTAKE RADIOIMMUNOASSAY KIT | KHQ | 1986-02-06 | 42 |
| K850254 | PARATHYROID HORMONE RADIOIMMUNOASSAY KIT | CEW | 1985-04-03 | 71 |
| K843635 | MATCHED COMPONENT SET FOR RADIOIMMUNO- | JKC | 1984-09-28 | 11 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cambridge Medical Technology.
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 Instruments, Inc. (13 510(k)s)
- Cambridge Medical Instruments, Inc. (8 510(k)s)
- Cambridge Bioscience Corp. (5 510(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 Medical Technology?
FDA lists 14 510(k) clearances under the applicant name “Cambridge Medical Technology” (first 1982, latest 1989), across 12 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 Cambridge Medical Technology?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cambridge Medical Technology is 37 days.
Which FDA product codes appear under Cambridge Medical Technology?
The most frequent FDA product codes under this applicant name are CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone, 2); CGR (Radioimmunoassay, Cortisol, 2); CDP (Radioimmunoassay, Total Triiodothyronine, 1).
Next steps
- See all 14 Cambridge Medical Technology clearances with predicates and recalls
- Run predicate analysis for product code CDZ, Cambridge Medical Technology'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.