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

Wellcome Diagnostics — Predicate Candidate Screening

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

73 daysmedian FDA review time

183 days90th percentile

28clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K915203	D-DIMER WELLCOTEST (HA10)	Wellcome Diagnostics	1992-01-31	74	0
K910797	STREPTEX ACID EXTRACTION KIT	Wellcome Diagnostics	1991-03-29	31	0
K895461	WELLCOLEX COLOUR SHIGELLA TEST ZC51	Wellcome Diagnostics	1990-01-11	127	0
K890146	WELLCOLEX COLOUR SALMONELLA TEST ZL 50	Wellcome Diagnostics	1989-02-16	34	0
K875311	WELLCOZYME HSV WZO2	Wellcome Diagnostics	1988-08-03	218	0
K861628	WELLCOZYME ROTAVIRUS WZ01	Wellcome Diagnostics	1987-01-21	267	0
K864206	REVEAL COLOUR STREP A ZL16	Wellcome Diagnostics	1987-01-13	78	0
K861634	THE WELLCOME ROTAVIRUS LATEX TEST ZL40	Wellcome Diagnostics	1986-10-29	183	0
K854851	WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24	Wellcome Diagnostics	1986-02-04	61	0
K854852	WELLCOGEN BACTERIAL ANTIGEN KIT	Wellcome Diagnostics	1986-02-04	61	0
K851691	WILLCOGEN MENINGITIDIS KIT ZL25	Wellcome Diagnostics	1985-06-10	48	0
K844762	MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51	Wellcome Diagnostics	1985-06-04	179	0
K851949	STAPHAUREX ZL30	Wellcome Diagnostics	1985-05-22	19	0
K842827	STREPTEX DIRECT A ZL14	Wellcome Diagnostics	1984-08-16	27	0
K842828	STREPTEX ZL01	Wellcome Diagnostics	1984-08-15	26	2
K841376	WELLCOGEN S. PNEUMONIAE	Wellcome Diagnostics	1984-05-02	29	0
K840210	REPTILASE-R HA35	Wellcome Diagnostics	1984-04-23	95	0
K840211	FIBRI-PREST AUTOMATE HA34	Wellcome Diagnostics	1984-03-02	43	1
K833077	WELLCOGEN H. INFLUENZAL ZL21	Wellcome Diagnostics	1984-01-10	123	0
K833063	WELLCOGEN N. MENINGITIDIS A,C,Y W135	Wellcome Diagnostics	1984-01-10	123	0
K832591	DIACROM *PLG	Wellcome Diagnostics	1983-11-21	111	0
K832373	DIACROM * HEPARIN	Wellcome Diagnostics	1983-09-29	73	0
K832372	DIACROM * FACTOR X KIT HA31	Wellcome Diagnostics	1983-09-29	73	0
K832592	DIACROM * ATIII	Wellcome Diagnostics	1983-09-29	58	0
K831073	DAC-CEL HCG-MCA KIT RD52	Wellcome Diagnostics	1983-09-01	150	0
K831069	DAC-CEL PTH KIT RD51	Wellcome Diagnostics	1983-06-16	73	0
K830204	DAC-CEL DIAGNATAL HCG STANDARDS RD49	Wellcome Diagnostics	1983-02-18	29	0
K830203	DAC-CEL DIAGNATAL RD 50	Wellcome Diagnostics	1983-02-18	29	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