Wellcome Diagnostics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
28
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K915203D-DIMER WELLCOTEST (HA10)January 31, 1992
K910797STREPTEX ACID EXTRACTION KITMarch 29, 1991
K895461WELLCOLEX COLOUR SHIGELLA TEST ZC51January 11, 1990
K890146WELLCOLEX COLOUR SALMONELLA TEST ZL 50February 16, 1989
K875311WELLCOZYME HSV WZO2August 3, 1988
K861628WELLCOZYME ROTAVIRUS WZ01January 21, 1987
K864206REVEAL COLOUR STREP A ZL16January 13, 1987
K861634THE WELLCOME ROTAVIRUS LATEX TEST ZL40October 29, 1986
K854851WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24February 4, 1986
K854852WELLCOGEN BACTERIAL ANTIGEN KITFebruary 4, 1986
K851691WILLCOGEN MENINGITIDIS KIT ZL25June 10, 1985
K844762MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51June 4, 1985
K851949STAPHAUREX ZL30May 22, 1985
K842827STREPTEX DIRECT A ZL14August 16, 1984
K842828STREPTEX ZL01August 15, 1984
K841376WELLCOGEN S. PNEUMONIAEMay 2, 1984
K840210REPTILASE-R HA35April 23, 1984
K840211FIBRI-PREST AUTOMATE HA34March 2, 1984
K833063WELLCOGEN N. MENINGITIDIS A,C,Y W135January 10, 1984
K833077WELLCOGEN H. INFLUENZAL ZL21January 10, 1984