FDA Product Code
FDA Product Code JGZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1770
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K904049 | ROCHE COBAS READY RENAL PROFILE REAGENT STRIP | Roche Diagnostic Systems, Inc. | 1990-10-12 | Traditional | PDF ↗ |
| K896236 | COBAS READY BUN REAGENT | Roche Diagnostic Systems, Inc. | 1990-02-27 | Traditional | PDF ↗ |
| K883327 | CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST | Heraeus Kulzer, Inc. | 1989-01-23 | Traditional | PDF ↗ |
| K863901 | IQ UREA NITROGEN | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-11-24 | Traditional | PDF ↗ |
| K842772 | PHARMACIA B2-MICRO RIA | Pharmacia, Inc. | 1984-11-01 | Traditional | PDF ↗ |
| K840213 | BLOOD UREA NITROGEN REAGENT SYS | Sclavo, Inc. | 1984-03-19 | Traditional | PDF ↗ |
| K820418 | K.D. COLORIMETRIC BLOOD UREA N2 TEST | King Diagnostics, Inc. | 1982-03-11 | Traditional | PDF ↗ |
| K810087 | UREA NITROGEN, KINETIC | Bio-Analytics Laboratories, Inc. | 1981-02-26 | Traditional | PDF ↗ |
| K801269 | SERALYZER BLOOD UREA NITROGEN(BUN) | Miles Laboratories, Inc. | 1980-07-08 | Traditional | PDF ↗ |
| K792362 | BLOOD UREA NITROGEN REAGENT | Connecticut Diagnostics, Ltd. | 1979-12-06 | Traditional | PDF ↗ |
| K770504 | REAGENT SYSTEM | American Monitor Corp. | 1977-06-27 | Traditional | PDF ↗ |
Product code JGZ · Class II · Clinical Chemistry. Data: openFDA.