FDA 510(k) Applications for Medical Device Product Code "JIQ"
|
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 |