FDA 510(k) Applications for Medical Device:
Biosensor, Immunoassay, Cpk Or Isoenzymes

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K033155 BIOCENTREX 6100 BRISTOL PARKWAY
CULVER CITY CA 90230
K051433 I-STAT CORPORATION 104 WINDSOR CENTER DRIVE
EAST WINDSOR NJ 08520
K984433 QUANTECH LTD. 9418 LASAINE AVE.
NORTHRIDGE CA 91325




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