FDA 510(k) Applications for Medical Device:
Enzyme Immunoassay, Digoxin

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K061249 ABBOTT LABORATORIES D 9VA, BLDG. AP6C-2
ABBOTT PARK IL 60064-3500
K980521 BAYER CORP. 511 BENEDICT AVE.
TARRYTOWN NY 10591-5097
K033007 BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE.
TARRYTOWN NY 10591-5097
K983151 BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110
BREA CA 92822
K982935 BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104
BREA CA 92822-8000
K963062 BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD.
BREA CA 92621
K082953 BIOKIT S.A. CAN MALE S/N
BARCELONA 08186
K970881 BOEHRINGER MANNHEIM CORP. 2400 BISSO LN.
CONCORD CA 94524
K970883 BOEHRINGER MANNHEIM CORP. 2400 BISSO LN.
CONCORD CA 94524
K973112 BOEHRINGER MANNHEIM CORP. 2400 BISSO LN.
CONCORD CA 94524
K012301 DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST.
LOS ANGELES CA 90045-5597
K963835 DIAGNOSTIC REAGENTS, INC. 601 CALIFORNIA AVE.
SUNNYVALE CA 94086
K983323 DIAGNOSTIC REAGENTS, INC. 601 CALIFORNIA AVE.
SUNNYVALE CA 94086
K011302 RANDOX LABORATORIES, LTD. 55 DIAMOND RD.
CRUMLIN, CO. ANTRIM BT29 4QY
K102346 RANDOX LABORATORIES, LTD. 55 DIAMOND RD.
CRUMLIN, COUNTY ANTRIM BT29 4QY
K153301 ROCHE DIAGNOSTICS 9115 HAGUE ROAD
INDIANAPOLIS IN 46250
K023058 SERADYN 7998 GEORGETOWN RD.
INDIANAPOLIS IN 46268
K093441 SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101
NEWARK DE 19714-6101
K193397 Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue
Tarrytown NY 10591
K972794 SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE.
ST.LOUIS MO 63103
K011920 SYVA CO., DADE BEHRING, INC. 20400 MARIANI AVE.
CUPERTINO CA 95014




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