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

Burroughs Wellcome Co. — Predicate Candidate Screening

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

29 daysmedian FDA review time

64 days90th percentile

17clearances measured

K-number	Device	Applicant	Decided	Review days
K820069	WELLCOGEN GROUP B	Burroughs Wellcome Co.	1982-02-18	37
K813508	SAC-CEL	Burroughs Wellcome Co.	1981-12-29	14
K810215	DAC-CEL HCG	Burroughs Wellcome Co.	1981-04-17	80
K810214	DAC-CEL DIAGNATAL	Burroughs Wellcome Co.	1981-03-06	38
K810213	DAC-CEL TSH	Burroughs Wellcome Co.	1981-02-10	14
K810212	DAC-CEL T3 UPTAKE	Burroughs Wellcome Co.	1981-02-10	14
K791231	DAC-CEL T4	Burroughs Wellcome Co.	1979-09-04	64
K791232	DAC-CEL T3	Burroughs Wellcome Co.	1979-09-04	64
K781607	STREP-TEX	Burroughs Wellcome Co.	1978-10-17	29
K780873	THYMUNE-M	Burroughs Wellcome Co.	1978-06-14	15
K780874	THYMUNE-T	Burroughs Wellcome Co.	1978-06-14	15
K780475	DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT	Burroughs Wellcome Co.	1978-04-24	31
K771560	TOXHA TEST	Burroughs Wellcome Co.	1977-09-15	31
K771583	FLUORESCENT ANTI. ANTI-HUMAN C3	Burroughs Wellcome Co.	1977-09-02	15
K771562	AGGLUTINATING SERUM W135	Burroughs Wellcome Co.	1977-08-25	10
K771139	CRP-WELLCOTEST	Burroughs Wellcome Co.	1977-07-14	17
K770269	CAMMADISK DIGOXIN	Burroughs Wellcome Co.	1977-03-16	33

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