Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cambridge Bioscience Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
113 daysmedian FDA review time
203 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K890281 | HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES | Cambridge Bioscience Corp. | 1989-03-15 | 57 | 0 |
| K881894 | ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48) | Cambridge Bioscience Corp. | 1988-07-08 | 64 | 0 |
| K873082 | ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST | Cambridge Bioscience Corp. | 1988-02-24 | 203 | 0 |
| K873312 | ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST | Cambridge Bioscience Corp. | 1988-02-24 | 190 | 0 |
| K852969 | ROTACLONE ROTAVIRUS DIAGNOSTIC KIT | Cambridge Bioscience Corp. | 1985-11-05 | 113 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda