FDA Product Code
FDA Product Code CDL — 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 |
|---|---|---|---|---|---|
| K896845 | RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT | Reagents Applications, Inc. | 1990-02-16 | Traditional | PDF ↗ |
| K893128 | STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010 | Stanbio Laboratory | 1989-07-25 | Traditional | PDF ↗ |
| K871651 | COLORIMETRIC BUN REAGENT KIT | Biochemical Trade, Inc. | 1987-05-12 | Traditional | PDF ↗ |
| K864742 | UREA NITROGEN(BUN), COLORIMETRIC METHOD | Tech-Co, Inc. | 1987-01-13 | Traditional | PDF ↗ |
| K863889 | UREA NITROGEN TEST | U. S. Diagnostics, Inc. | 1986-11-24 | Traditional | PDF ↗ |
| K863076 | UREAFAST | J. D. Assoc. | 1986-09-09 | Traditional | PDF ↗ |
| K860154 | BUN (ENZYMATIC BERTHELOT) REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-06 | Traditional | PDF ↗ |
| K831414 | COLORIMETRIC BUN | Bio-Analytics Laboratories, Inc. | 1983-06-16 | Traditional | PDF ↗ |
| K822237 | UREA NITROGEN REAGENT SET (MOD. BERTHEL | Sterling Biochemical, Inc. | 1982-08-16 | Traditional | PDF ↗ |
| K810261 | EUROCHIMA UREA NITROGEN | Volu Sol Medical Industries | 1981-02-10 | Traditional | PDF ↗ |
| K801727 | DATA-ZYME UREA NITROGEN, COLORIMETRIC | Data Medical Associates, Inc. | 1980-09-09 | Traditional | PDF ↗ |
| K800902 | BUN-COLOR 2, BLOOD UREA NITROGEN TEST | Sclavo, Inc. | 1980-06-09 | Traditional | PDF ↗ |
| K792417 | ELVI BLOOD UREA NITROGEN | Volu Sol Medical Industries | 1979-12-07 | Traditional | PDF ↗ |
| K781899 | UREA NITROGEN TEST | Wako Intl., Inc. | 1978-12-20 | Traditional | PDF ↗ |
| K781306 | UREA NITROGEN TEST KIT | Analytical & Research Chemicals, Inc. | 1978-08-31 | Traditional | PDF ↗ |
| K761152 | S-UREA-N, IN VITRO DIAG FOR BUN | Advanced Biomedical Methods, Inc. | 1976-12-09 | Traditional | PDF ↗ |
Product code CDL · Class II · Clinical Chemistry. Data: openFDA.