FDA Product Code
FDA Product Code CDS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1770
510(k) Clearances — 15 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K171247 | epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test | Epocal, Inc. | 2018-01-17 | Traditional | PDF ↗ |
| K040973 | BUN REAGENT | Genchem, Inc. | 2004-12-27 | Traditional | PDF ↗ |
| K033056 | BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT | Diamond Diagnostics, Inc. | 2004-01-30 | Traditional | PDF ↗ |
| K925550 | HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 | Hichem Diagnostics | 1993-04-20 | Traditional | PDF ↗ |
| K860543 | BLOOD UREA NITROGEN (BUN) TESTCARD | Ilex Corp. | 1986-04-21 | Traditional | PDF ↗ |
| K855091 | CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS | Sen Tech Medical Corp. | 1986-03-14 | Traditional | PDF ↗ |
| K812308 | LANCER BUN RATE REAGENT KIT | Sherwood Medical Co. | 1981-08-31 | Traditional | PDF ↗ |
| K811193 | BUN RATE REAGENT | Chem-Elec, Inc. | 1981-07-10 | Traditional | PDF ↗ |
| K800616 | BUN REAGENT KIT #88108 | Hi Chem, Inc. | 1980-04-10 | Traditional | PDF ↗ |
| K800590 | BUN KIT | Nobel Scientific Industries, Inc. | 1980-04-04 | Traditional | PDF ↗ |
| K800071 | BUN REAGENT KIT | Fisher Scientific Co., LLC | 1980-02-05 | Traditional | PDF ↗ |
| K791018 | FERMCOTEST R BUN RATE REAGENT TEST KIT | Fermco Biochemics, Inc. | 1979-07-17 | Traditional | PDF ↗ |
| K771060 | DIAG. CONDUCTA RATE BUN REAG. SET | J.T. Baker Chemical Co. | 1977-07-21 | Traditional | PDF ↗ |
| K761061 | BLOOD-UREA-NITROGEN (BUN) ANALYZER 2 | Beckman Instruments, Inc. | 1977-01-25 | Traditional | PDF ↗ |
| K760430 | BUN-REATIVE | Boehringer Mannheim Corp. | 1976-11-01 | Traditional | PDF ↗ |
Product code CDS · Class II · Clinical Chemistry. Data: openFDA.