FDA 510(k) Applications for Medical Device Product Code "CDN"
(Urease, Photometric, Urea Nitrogen)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K113389 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. | ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT | 08/10/2012 |
| K103615 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. | ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD | 09/08/2011 |
| K123322 | ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC | ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT | 05/21/2013 |
| K972012 | CHOLESTECH CORP. | CHOLESTECH BUN/CREATININE TEST SYSTEM | 07/24/1997 |
| K132462 | HITACHI CHEMICAL DIAGNOSTICS, INC. | S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE | 10/28/2013 |
| K961196 | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. | EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) | 05/15/1996 |
| K001885 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 | 07/20/2000 |
| K190326 | Ortho-Clinical Diagnostics, Inc. | VITROS XT Chemistry Products UREA-CREA Slides | 03/14/2019 |
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