510(k) K040973
- Device
- BUN REAGENT
- Applicant
- GENCHEM, INC.
- 510(k) number
- K040973
- Product code
- CDS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-12-27
- Date received
- 2004-04-14
- Regulation
- 862.1770
- Classification name
- Electrode, Ion Specific, Urea Nitrogen
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- C.C. ALLAIN
- Address
- 471 W. Lambert Rd., Suite 107 Brea CA US 92821 92821
FDA Registration Numbers#
- 3005643513
- 9610126
- 3006198300
- 2245578
- 3023162659
- 3003795116
- 1219029
- 3003030793
- 2030861
- 2050012
- 2050010
- 3012817228
- 3004102403
- 3004959793
Source Documents#
Other 510(k) Records For Product Code CDS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171247 | epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test | Epocal, Inc. | 2018-01-17 |
| K033056 | BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT | Diamond Diagnostics, Inc. | 2004-01-30 |
| K925550 | HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 | Hichem Diagnostics | 1993-04-20 |
| K860543 | BLOOD UREA NITROGEN (BUN) TESTCARD | Ilex Corp. | 1986-04-21 |
| K855091 | CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS | Sen Tech Medical Corp. | 1986-03-14 |
| K812308 | LANCER BUN RATE REAGENT KIT | Sherwood Medical Co. | 1981-08-31 |
| K811193 | BUN RATE REAGENT | Chem-Elec, Inc. | 1981-07-10 |
| K800616 | BUN REAGENT KIT #88108 | Hi Chem, Inc. | 1980-04-10 |
| K800590 | BUN KIT | Nobel Scientific Industries, Inc. | 1980-04-04 |
| K800071 | BUN REAGENT KIT | Fisher Scientific Co., LLC | 1980-02-05 |
| K791018 | FERMCOTEST R BUN RATE REAGENT TEST KIT | Fermco Biochemics, Inc. | 1979-07-17 |
| K771060 | DIAG. CONDUCTA RATE BUN REAG. SET | J.T. Baker Chemical Co. | 1977-07-21 |
| K761061 | BLOOD-UREA-NITROGEN (BUN) ANALYZER 2 | Beckman Instruments, Inc. | 1977-01-25 |
| K760430 | BUN-REATIVE | Boehringer Mannheim Corp. | 1976-11-01 |
Legacy Summary#
summary
FDA Review#
Decision Summary