FDA 510(k) Applications for Medical Device:
Nitroprusside, Ketones (Urinary, Non-Quant.)

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K060768 ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD.
ALAMEDA CA 94502
K875029 ABBOTT LABORATORIES ONE ABBOTT PARK RD.
ABBOTT PARK IL 60064 3500
K170587 ACON Laboratories, Inc. 10125 Mesa Rim Road
San Diego CA 92121
K182593 Apex Biotechnology Corp. No. 7, Li-Hsin Road V, Hsinchu Science Park
Hsinchu 30078
K910108 GDS DIAGNOSTICS 25235 LEER DR.
ELKHART IN 46515
K911801 GDS TECHNOLOGY, LLC. 25235 LEER DR.
ELKHART IN 46515
K830976 HELENA LABORATORIES
K170463 i-SENS, Inc. 43,Banpo-daero 28-gil
Seoul 06646
K912373 IHARA MEDICS U.S., INC. 25030 AVENUE TIBBITS, UNIT K
VALENCIA CA 91355
K903367 IHARA MEDICS U.S., INC. 25030 AVENUE TIBBITS, UNIT K
VALENCIA CA 91355
K903366 IHARA MEDICS U.S., INC. 25030 AVENUE TIBBITS, UNIT K
VALENCIA CA 91355
K903365 IHARA MEDICS U.S., INC. 25030 AVENUE TIBBITS, UNIT K
VALENCIA CA 91355
K841715 KYOTO DIAGNOSTICS, INC.
K831499 LAPROL SCIENTIFIC, INC.
K801270 MILES LABORATORIES, INC.
K033114 NEO DIAGNOSTICS, INC 10532 WALKER ST.
CYPRESS CA 90630
K830975 NEW DIRECTIONS CO.
K953680 POLYMER TECHNOLOGY INTL. 1871 N.W. GILMAN BLVD.
ISSAQUAH WA 98027
K953662 POLYMER TECHNOLOGY INTL. 1871 N.W. GILMAN BLVD.
ISSAQUAH WA 98027
K850368 SIGMA CHEMICAL CO. P.O. BOX 14508
ST. LOUIS MO 63178
K173345 TaiDoc Technology Corporation B1-7F, No. 127, Wugong 2nd Rd., Wugu District
New Taipei City 24888
K003987 TECO DIAGNOSTICS 4925 EAST HUNTER AVE.
ANAHEIM CA 92807




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