FDA 510(k) Applications for Medical Device:
Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K013643 AUSAM BIOTECTHNOLOGIES INC 50 ROCKEFELLER PLAZA
NEW YORK NY 10020
K965035 BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD.
BREA CA 92821-6208
K971458 DIAGNOSTIC SPECIALTIES 4 LEONARD ST.
METUCHEN NJ 08840-4338
K991800 OSBORN GROUP, INC. 14901 WEST 117TH ST.
OLATHE KS 66062
K141925 Roche Diagnostics Operations (RDO) 9115 Hague Road
Indianapolis IN 46250




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