FDA 510(k) Applications Submitted by WELLCOME DIAGNOSTICS

FDA 510(k) Number Submission Date Device Name Applicant
K840210 01/19/1984 REPTILASE-R HA35 WELLCOME DIAGNOSTICS
K840211 01/19/1984 FIBRI-PREST AUTOMATE HA34 WELLCOME DIAGNOSTICS
K830203 01/20/1983 DAC-CEL DIAGNATAL RD 50 WELLCOME DIAGNOSTICS
K830204 01/20/1983 DAC-CEL DIAGNATAL HCG STANDARDS RD49 WELLCOME DIAGNOSTICS
K841376 04/03/1984 WELLCOGEN S. PNEUMONIAE WELLCOME DIAGNOSTICS
K831069 04/04/1983 DAC-CEL PTH KIT RD51 WELLCOME DIAGNOSTICS
K831073 04/04/1983 DAC-CEL HCG-MCA KIT RD52 WELLCOME DIAGNOSTICS
K832372 07/18/1983 DIACROM * FACTOR X KIT HA31 WELLCOME DIAGNOSTICS
K832373 07/18/1983 DIACROM * HEPARIN WELLCOME DIAGNOSTICS
K842827 07/20/1984 STREPTEX DIRECT A ZL14 WELLCOME DIAGNOSTICS
K842828 07/20/1984 STREPTEX ZL01 WELLCOME DIAGNOSTICS
K832591 08/02/1983 DIACROM *PLG WELLCOME DIAGNOSTICS
K832592 08/02/1983 DIACROM * ATIII WELLCOME DIAGNOSTICS
K833063 09/09/1983 WELLCOGEN N. MENINGITIDIS A,C,Y W135 WELLCOME DIAGNOSTICS
K833077 09/09/1983 WELLCOGEN H. INFLUENZAL ZL21 WELLCOME DIAGNOSTICS
K895461 09/06/1989 WELLCOLEX COLOUR SHIGELLA TEST ZC51 WELLCOME DIAGNOSTICS
K910797 02/26/1991 STREPTEX ACID EXTRACTION KIT WELLCOME DIAGNOSTICS
K915203 11/18/1991 D-DIMER WELLCOTEST (HA10) WELLCOME DIAGNOSTICS
K861634 04/29/1986 THE WELLCOME ROTAVIRUS LATEX TEST ZL40 WELLCOME DIAGNOSTICS
K851691 04/23/1985 WILLCOGEN MENINGITIDIS KIT ZL25 WELLCOME DIAGNOSTICS
K851949 05/03/1985 STAPHAUREX ZL30 WELLCOME DIAGNOSTICS
K854851 12/05/1985 WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24 WELLCOME DIAGNOSTICS
K854852 12/05/1985 WELLCOGEN BACTERIAL ANTIGEN KIT WELLCOME DIAGNOSTICS
K844762 12/07/1984 MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51 WELLCOME DIAGNOSTICS
K890146 01/13/1989 WELLCOLEX COLOUR SALMONELLA TEST ZL 50 WELLCOME DIAGNOSTICS
K861628 04/29/1986 WELLCOZYME ROTAVIRUS WZ01 WELLCOME DIAGNOSTICS
K864206 10/27/1986 REVEAL COLOUR STREP A ZL16 WELLCOME DIAGNOSTICS
K875311 12/29/1987 WELLCOZYME HSV WZO2 WELLCOME DIAGNOSTICS


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