Bun (Enzymatic Berthelot) Reagent Set
FDA 510(k) K860154 · Sterling Diagnostics, Inc.
510(k) numberK860154
Submission
- Device name
- Bun (Enzymatic Berthelot) Reagent Set
- Applicant
- Sterling Diagnostics, Inc.
Sterling Heights, MI, US - Received
- January 16, 1986
- Decision date
- February 6, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CDL – Berthelot Indophenol, Urea Nitrogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1770
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CDL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K896845 | Raichem(Tm) Urea Nitrogen (Color) ReagentCDL · Traditional | Reagents Applications, Inc. | 02/16/1990SE |
| K893128 | Stanbio Enzymatic Urea Nitrogen Determinat #2010CDL · Traditional | Stanbio Laboratory | 07/25/1989SE |
| K871651 | Colorimetric Bun Reagent KitCDL · Traditional | Biochemical Trade, Inc. | 05/12/1987SE |
| K864742 | Urea Nitrogen(Bun), Colorimetric MethodCDL · Traditional | Tech-Co, Inc. | 01/13/1987SE |
| K863889 | Urea Nitrogen TestCDL · Traditional | U. S. Diagnostics, Inc. | 11/24/1986SE |
| K863076 | UreafastCDL · Traditional | J. D. Assoc. | 09/09/1986SE |
| K831414 | Colorimetric BunCDL · Traditional | Bio-Analytics Laboratories, Inc. | 06/16/1983SE |
| K822237 | Urea Nitrogen Reagent Set (Mod. BerthelCDL · Traditional | Sterling Biochemical, Inc. | 08/16/1982SE |
| K810261 | Eurochima Urea NitrogenCDL · Traditional | Volu Sol Medical Industries | 02/10/1981SE |
| K801727 | Data-Zyme Urea Nitrogen, ColorimetricCDL · Traditional | Data Medical Associates, Inc. | 09/09/1980SE |
More from Data Medical Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K921412 | Microprotein Reagent SetCEK · Traditional | 01/21/1993SE |
| K914609 | Triglycerides Reagent SetCDT · Traditional | 11/07/1991SE |
| K914039 | Sodium Reagent SetCEI · Traditional | 10/31/1991SE |
| K914040 | Phospholipid Reagent SetJNT · Traditional | 10/30/1991SE |
| K862255 | Lactate Dehydrogenase (LDH) Reagent Set (UV Rate)CFJ · Traditional | 07/29/1986SE |
| K861962 | Vanilmandelic Acid (Vma) Reagent SetCDF · Traditional | 07/07/1986SE |
| K862256 | Alkaline Phosphatase (PNPP Rate) Reagent SetCJE · Traditional | 07/01/1986SE |
| K862210 | Urea Nitrogen (GLDH) Reagent Set (UV)CDQ · Traditional | 07/01/1986SE |
| K862209 | Alt (SGPT) Reagent Set (UV Rate)CKA · Traditional | 06/25/1986SE |
| K861855 | Hydroxybutyrate Dehydrogenase (HBD) Reagent SetJKF · Traditional | 06/16/1986SE |
Questions and answers
When was Bun (Enzymatic Berthelot) Reagent Set cleared by the FDA?
Bun (Enzymatic Berthelot) Reagent Set (K860154) received a 510(k) decision of Substantially Equivalent on February 6, 1986, 21 days after the submission was received.
What is the product code of K860154?
The FDA product code is CDL – Berthelot Indophenol, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.