CDN — Urease, Photometric, Urea Nitrogen Class II
FDA product code CDN covers "Urease, Photometric, Urea Nitrogen", a Class II medical device regulated under 21 CFR 862.1770. Submissions are reviewed by the Clinical Chemistry panel. At least 16 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CDN
- Device Class
- Class II
- Regulation Number
- 862.1770
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K190326 | Ortho-Clinical Diagnostics | VITROS XT Chemistry Products UREA-CREA Slides | Mar 14, 2019 |
| K132462 | Hitachi Chemical Diagnostics | S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE | Oct 28, 2013 |
| K123322 | Alfa Wassermann Diagnostics Technologies | ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAG | May 21, 2013 |
| K113389 | Alfa Wassermann Diagnostic Technologies | ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT | Aug 10, 2012 |
| K103615 | Alfa Wassermann Diagnostic Technologies | ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANI | Sep 8, 2011 |
| K001885 | Ortho-Clinical Diagnostics | VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRAT | Jul 20, 2000 |
| K972012 | Cholestech | CHOLESTECH BUN/CREATININE TEST SYSTEM | Jul 24, 1997 |
| K961196 | Johnson And Johnson Clinical Diagnostics | EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) | May 15, 1996 |
| K943042 | Prisma Systems | BUN QVET | Dec 29, 1994 |
| K922969 | King Diagnostics | KING DIAGNOSTICS UREA NITROGEN REAGENT | Oct 13, 1992 |
| K914903 | Em Diagnostic Systems | QUICKSTART UREA NITROGEN | Dec 31, 1991 |
| K822154 | Dow Chemical | UREA NITROGEN (ENZYMATIC) DETERMINATION | Aug 5, 1982 |
| K802518 | Nobel Scientific Industries | BUN REAGENT ASTRA 4 & 8 ANALYZERS | Nov 12, 1980 |
| K792328 | Boehringer Mannheim | STATTEK BUN | Dec 18, 1979 |
| K781253 | Coulter Electronics | BUN (UREASE) REAGENT | Aug 21, 1978 |
| K771442 | Instrumentation Laboratory | MULTISTAT III UREA NITROGEN TEST | Aug 22, 1977 |