FDA 510(k) Applications for Medical Device:
Acid, Lactic, Enzymatic Method

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K130113 ABAXIS, INC. 3240 WHIPPLE RD.
UNION CITY CA 94587
K112430 ABBOTT PONT OF CARE INC 400 COLLEGE ROAD EAST
PRINCETON NJ 08540
K013938 DIAMETRICS MEDICAL, INC. 2658 PATTON RD.
SAINT PAUL MN 55113
K093297 EPOCAL, INC. 2060 WALKLEY RD.
OTTAWA, ONTARIO K1G-3P5
K982071 I-STAT CORP. 303 COLLEGE RD. EAST
PRINCETON NJ 08540
K011478 I-STAT CORP. 104 WINDSOR CENTER DR.
EAST WINDSOR NJ 08520
K971944 JWT, INC. 115 RESEARCH DR.
BETHLEHEM PA 18015
K980908 KDK CORP. 57 NISHIAKETA-CHO,
KYOTO 601
K100602 NOVA BIOMEDICAL CORP. 200 PROSPECT ST.
WALTHAM MA 02454-9141
K112955 NOVA BIOMEDICAL CORPORATION 200 Prospect St
WALTHAM MA 02454
K113216 SIEMENS HEALTHCARE DIAGNOSTICS 2 EDGEWATER DRIVE
NORWOOD MA 02062




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