FDA Product Code
FDA Product Code CDN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1770
510(k) Clearances — 16 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K190326 | VITROS XT Chemistry Products UREA-CREA Slides | Ortho-Clinical Diagnostics, Inc. | 2019-03-14 | Traditional | PDF ↗ |
| K132462 | S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE | Hitachi Chemical Diagnostics, Inc. | 2013-10-28 | Traditional | PDF ↗ |
| K123322 | ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT | Alfa Wassermann Diagnostics Technologies, LLC | 2013-05-21 | Traditional | PDF ↗ |
| K113389 | ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-08-10 | Traditional | PDF ↗ |
| K103615 | ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD | Alfa Wassermann Diagnostic Technologies, Inc. | 2011-09-08 | Traditional | PDF ↗ |
| K001885 | VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 | Ortho-Clinical Diagnostics, Inc. | 2000-07-20 | Special | PDF ↗ |
| K972012 | CHOLESTECH BUN/CREATININE TEST SYSTEM | Cholestech Corp. | 1997-07-24 | Traditional | PDF ↗ |
| K961196 | EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-05-15 | Traditional | PDF ↗ |
| K943042 | BUN QVET | Prisma Systems | 1994-12-29 | Traditional | PDF ↗ |
| K922969 | KING DIAGNOSTICS UREA NITROGEN REAGENT | King Diagnostics, Inc. | 1992-10-13 | Traditional | PDF ↗ |
| K914903 | QUICKSTART UREA NITROGEN | Em Diagnostic Systems, Inc. | 1991-12-31 | Traditional | PDF ↗ |
| K822154 | UREA NITROGEN (ENZYMATIC) DETERMINATION | The Dow Chemical Co. | 1982-08-05 | Traditional | PDF ↗ |
| K802518 | BUN REAGENT ASTRA 4 & 8 ANALYZERS | Nobel Scientific Industries, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K792328 | STATTEK BUN | Boehringer Mannheim Corp. | 1979-12-18 | Traditional | PDF ↗ |
| K781253 | BUN (UREASE) REAGENT | Coulter Electronics, Inc. | 1978-08-21 | Traditional | PDF ↗ |
| K771442 | MULTISTAT III UREA NITROGEN TEST | Instrumentation Laboratory CO | 1977-08-22 | Traditional | PDF ↗ |
Product code CDN · Class II · Clinical Chemistry. Data: openFDA.