Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Cambridge Medical Technology · Predicate Candidate Screening

14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

38 daysmedian FDA review time

71 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K890837	RIA-GNOST INSULIN	Cambridge Medical Technology	1989-04-26	64
K890697	RIA-GNOST FERRITIN	Cambridge Medical Technology	1989-03-16	34
K890836	RIA-GNOST PROGESTERONE	Cambridge Medical Technology	1989-03-16	23
K873737	NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY	Cambridge Medical Technology	1987-11-24	70
K870573	T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT	Cambridge Medical Technology	1987-04-22	71
K862871	RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL	Cambridge Medical Technology	1986-08-19	21
K860130	TESTOSTERONE COATED TUBES RADIOIMMUNOASSAY KIT	Cambridge Medical Technology	1986-02-19	36
K855169	T3 UPTAKE RADIOIMMUNOASSAY KIT	Cambridge Medical Technology	1986-02-06	42
K850254	PARATHYROID HORMONE RADIOIMMUNOASSAY KIT	Cambridge Medical Technology	1985-04-03	71
K843635	MATCHED COMPONENT SET FOR RADIOIMMUNO-	Cambridge Medical Technology	1984-09-28	11
K841042	MATCHED COMPONENT SET RADIOIMMUNOASSAY	Cambridge Medical Technology	1984-04-19	38
K834080	MATCHED COMPONENT SET FOR DIGITOXIN	Cambridge Medical Technology	1984-02-04	68
K830148	CORTISOL KIT	Cambridge Medical Technology	1983-02-09	23
K821811	125I DIGOXIN RADIOIMMUNOASSAY KIT	Cambridge Medical Technology	1982-07-02	14

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