510(k) K770470
- Device
- WORTHINGTON BUN
- Applicant
- Worthington Biochemical Corp.
- 510(k) number
- K770470
- Product code
- CDW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-06-02
- Date received
- 1977-03-10
- Regulation
- 862.1770
- Classification name
- Diacetyl-Monoxime, Urea Nitrogen
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CDW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K874532 | BLOOD UREA NITROGEN | Catachem, Inc. | 1988-01-05 |
| K871320 | FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814 | American Research Products Co. | 1987-04-22 |
| K863425 | AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346 | American Research Products Co. | 1986-10-01 |
| K861775 | TWIN BUN/GLUCOSE | Boehringer Mannheim Corp. | 1986-06-27 |
| K860419 | UREA NITROGEN REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-11 |
| K850937 | UREA | Dilab, Inc. | 1985-06-10 |
| K844156 | UREA NITROGEN REAGENT SET | Livonia Diagnostics, Inc. | 1984-11-13 |
| K841068 | UREA NITROGEN REAGENT SET | Medical Specialties, Inc. | 1984-05-01 |
| K822323 | ULTRACHEM BUN-UV, 65080 & 65081 | Harleco Diagnostics | 1982-09-02 |
| K821212 | UREA NITROGEN REAGENT SET | Omega Medical Electronics | 1982-07-22 |
| K813415 | UREA NITROGEN REAGENT SET | Anco Medical Reagents & Assoc. | 1981-12-31 |
| K802160 | BUN COLOR REAGENT & BUN ACID USED | Panmed, Inc. | 1980-10-10 |
| K800673 | SMAC REPLACEMENT REAGENTS/OF BUN-SERUM | Diagnostic Solutions, Inc. | 1980-05-28 |
| K781885 | SERUM, BLOOD UREA NITIOGEN | Fisher Scientific Co., LLC | 1978-12-20 |
| K781305 | UREA NITROGEN | Analytical & Research Chemicals, Inc. | 1978-08-31 |