FDA Product Code
FDA Product Code CDQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1770
510(k) Clearances — 117 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K812290 | FUN-UV SYSTEM PACK TEST | Boehringer Mannheim Corp. | 1981-08-31 | Traditional | PDF ↗ |
| K810794 | A-GENT UREA NITROGEN | Abbott Laboratories | 1981-04-01 | Traditional | PDF ↗ |
| K802061 | DATA-ZYME UREA NITROGEN REAGENT SET | Data Medical Associates, Inc. | 1980-09-26 | Traditional | PDF ↗ |
| K801116 | COBAS REAGENT FOR BUN | Roche Analytical Instruments, Inc. | 1980-06-17 | Traditional | PDF ↗ |
| K800719 | ENZYMATIC UREA NITROGEN REAGENT SET REVI | Macomb Chemical Co. | 1980-05-08 | Traditional | PDF ↗ |
| K800529 | CENTRIFICHEM BUN | Union Carbide Corp. | 1980-03-20 | Traditional | PDF ↗ |
| K800341 | BUN REAGENT | Gilford Diagnostics | 1980-03-12 | Traditional | PDF ↗ |
| K800128 | CENTRIFICHEM BUN | Union Carbide Corp. | 1980-02-13 | Traditional | PDF ↗ |
| K781782 | BUN | Gilford Diagnostics | 1979-01-10 | Traditional | PDF ↗ |
| K780943 | BUN TEST UNI-UV BLOOD UREA NITROGEN TEST | Sclavo, Inc. | 1978-07-27 | Traditional | PDF ↗ |
| K780534 | UREA NITROGEN (ENZYMATIC) | Macomb Chemical Co. | 1978-05-19 | Traditional | PDF ↗ |
| K780069 | BUN REAGNET SET | Medical Analysis Systems, Inc. | 1978-02-14 | Traditional | PDF ↗ |
| K771923 | FASTCHEM BUN | Boehringer Mannheim Corp. | 1977-11-11 | Traditional | PDF ↗ |
| K770654 | UN, UV DELTA TEST ASSAY | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-06-24 | Traditional | PDF ↗ |
| K770315 | BUN, ENZYMATIC | Icn Pharmaceuticals, Inc. | 1977-04-05 | Traditional | PDF ↗ |
| K761261 | ENZYMATIC BUN (RATE) REAGENT KIT | Beckman Instruments, Inc. | 1976-12-29 | Traditional | PDF ↗ |
| K760414 | ENZYMATIC BUN REAGENT KIT | Beckman Instruments, Inc. | 1976-11-05 | Traditional | PDF ↗ |
Product code CDQ · Class II · Clinical Chemistry. Data: openFDA.