Reagent, Bun (Urea Nitrogen) Determ.
FDA 510(k) K760478 · Simmler & Son, Inc.
510(k) numberK760478
Submission
- Device name
- Reagent, Bun (Urea Nitrogen) Determ.
- Applicant
- Simmler & Son, Inc.
Mchenry, IL, US - Received
- August 17, 1976
- Decision date
- October 29, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CDW – Diacetyl-Monoxime, Urea Nitrogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1770
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CDW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K874532 | Blood Urea NitrogenCDW · Traditional | Catachem, Inc. | 01/05/1988SE |
| K871320 | Flow-Pac Urea Nitrogen Reagent Set 2214, 2814CDW · Traditional | American Research Products Co. | 04/22/1987SE |
| K863425 | Amresco Flow Pac Urea Nitrogen Reagents #1346CDW · Traditional | American Research Products Co. | 10/01/1986SE |
| K861775 | Twin Bun/GlucoseCDW · Traditional | Boehringer Mannheim Corp. | 06/27/1986SE |
| K860419 | Urea Nitrogen Reagent SetCDW · Traditional | Sterling Diagnostics, Inc. | 02/11/1986SE |
| K850937 | UreaCDW · Traditional | Dilab, Inc. | 06/10/1985SE |
| K844156 | Urea Nitrogen Reagent SetCDW · Traditional | Livonia Diagnostics, Inc. | 11/13/1984SE |
| K841068 | Urea Nitrogen Reagent SetCDW · Traditional | Medical Specialties, Inc. | 05/01/1984SE |
| K822323 | Ultrachem Bun-Uv, 65080 & 65081CDW · Traditional | Harleco Diagnostics | 09/02/1982SE |
| K821212 | Urea Nitrogen Reagent SetCDW · Traditional | Omega Medical Electronics | 07/22/1982SE |
More from Omega Medical Electronics
| 510(k) | Device | Decision |
|---|---|---|
| K780817 | Globin-Terge · Traditional | 07/27/1978SE |
| K771906 | PhosphateCDT · Traditional | 12/06/1977SE |
| K771905 | Glycerol SubstrateCDT · Traditional | 12/06/1977SE |
| K771904 | Glycerol KinaseCDT · Traditional | 12/06/1977SE |
| K771903 | LipaseCDT · Traditional | 12/06/1977SE |
| K761086 | ReagentsJJC · Traditional | 01/12/1977SE |
| K760476 | Reagent, Lactate DehydrogenaseCFJ · Traditional | 11/01/1976SE |
| K760480 | Reagent, Total Protein DeterminationCEK · Traditional | 10/29/1976SE |
| K760479 | Reagent, Total Bilirubin DeterminationCIG · Traditional | 10/29/1976SE |
| K760477 | REAGENTS-4 for Uric Acid DeterminationCDH · Traditional | 10/29/1976SE |
Questions and answers
When was Reagent, Bun (Urea Nitrogen) Determ. cleared by the FDA?
Reagent, Bun (Urea Nitrogen) Determ. (K760478) received a 510(k) decision of Substantially Equivalent on October 29, 1976, 73 days after the submission was received.
What is the product code of K760478?
The FDA product code is CDW – Diacetyl-Monoxime, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.