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

FDA 510(k) Number Applicant Device Name Decision Date
K013643 AUSAM BIOTECTHNOLOGIES INC AUSAM TOTAL ALBUMIN ASSAY 08/14/2003
K965035 BECKMAN INSTRUMENTS, INC. IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT 04/17/1997
K971458 DIAGNOSTIC SPECIALTIES ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT 09/02/1997
K991800 OSBORN GROUP, INC. HEMOCHEK URINE COLLECTION KIT 09/24/1999
K141925 Roche Diagnostics Operations (RDO) TOTAL PROTEIN URINE/CSF GEN.3 12/09/2014


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