Cambridge Bioscience Corp.
Hopkinton, MA, US
Cambridge Bioscience Corp. appears in FDA device records in Hopkinton, MA. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 5
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 5 510(k) clearances for Cambridge Bioscience Corp. between 1985 and 1989. The busiest year on record is 1988, with 3. The most recent is 1989, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1988 | 3 |
| 1989 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K890281 | HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES | LSR | Substantially Equivalent | |
| K881894 | ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48) | GOD | Substantially Equivalent | |
| K873312 | ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST | GOD | Substantially Equivalent | |
| K873082 | ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST | GOD | Substantially Equivalent | |
| K852969 | ROTACLONE ROTAVIRUS DIAGNOSTIC KIT | LIQ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain