Wellcome Diagnostics

FDA 510(k) & PMA Approved Devices — 28 products

Total Devices28

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K915203	D-DIMER WELLCOTEST (HA10)	DAP	1992-01-31	View
510(k)	K910797	STREPTEX ACID EXTRACTION KIT	GTZ	1991-03-29	View
510(k)	K895461	WELLCOLEX COLOUR SHIGELLA TEST ZC51	GNB	1990-01-11	View
510(k)	K890146	WELLCOLEX COLOUR SALMONELLA TEST ZL 50	GRM	1989-02-16	View
510(k)	K875311	WELLCOZYME HSV WZO2	GQN	1988-08-03	View
510(k)	K861628	WELLCOZYME ROTAVIRUS WZ01	LIQ	1987-01-21	View
510(k)	K864206	REVEAL COLOUR STREP A ZL16	GTZ	1987-01-13	View
510(k)	K861634	THE WELLCOME ROTAVIRUS LATEX TEST ZL40	LIQ	1986-10-29	View
510(k)	K854852	WELLCOGEN BACTERIAL ANTIGEN KIT	GTJ	1986-02-04	View
510(k)	K854851	WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24	GTJ	1986-02-04	View
510(k)	K851691	WILLCOGEN MENINGITIDIS KIT ZL25	GTJ	1985-06-10	View
510(k)	K844762	MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51	GTJ	1985-06-04	View
510(k)	K851949	STAPHAUREX ZL30	GTN	1985-05-22	View
510(k)	K842827	STREPTEX DIRECT A ZL14	GTZ	1984-08-16	View
510(k)	K842828	STREPTEX ZL01	JTO	1984-08-15	View
510(k)	K841376	WELLCOGEN S. PNEUMONIAE	GWC	1984-05-02	View
510(k)	K840210	REPTILASE-R HA35	JCO	1984-04-23	View
510(k)	K840211	FIBRI-PREST AUTOMATE HA34	KQJ	1984-03-02	View
510(k)	K833063	WELLCOGEN N. MENINGITIDIS A,C,Y W135	GTJ	1984-01-10	View
510(k)	K833077	WELLCOGEN H. INFLUENZAL ZL21	GRD	1984-01-10	View