Colorimetric Bun Reagent Kit
FDA 510(k) K871651 · Biochemical Trade, Inc.
510(k) numberK871651
Submission
- Device name
- Colorimetric Bun Reagent Kit
- Applicant
- Biochemical Trade, Inc.
Miami, FL, US - Received
- April 28, 1987
- Decision date
- May 12, 1987
- 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 |
| 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 |
| K860154 | Bun (Enzymatic Berthelot) Reagent SetCDL · Traditional | Sterling Diagnostics, Inc. | 02/06/1986SE |
| 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 |
|---|---|---|
| K942958 | Creatine Kinase MB Determination (UV)JHW · Traditional | 11/21/1994SE |
| K910635 | Total Bilirubin Reagent SetCIG · Traditional | 05/15/1991SE |
| K910296 | Phosphorus (Inorganic) Test SystemCEO · Traditional | 02/27/1991SE |
| K905776 | Albumin Reagent SetCJW · Traditional | 02/26/1991SE |
| K905790 | Total Protein Reagent SetCEK · Traditional | 02/21/1991SE |
| K905650 | Kinetic Alkaline Phosphatase DeterminationCJE · Traditional | 02/13/1991SE |
| K905619 | Creatinine (Rate) Reagent SetCGX · Traditional | 02/13/1991SE |
| K905651 | Kinetic Amylase DeterminationJFJ · Traditional | 01/31/1991SE |
| K905649 | Gamma-Glutamyl Transferase DeterminationJQB · Traditional | 01/30/1991SE |
| K905588 | Creatine Kinase UV Reagent SetJHW · Traditional | 01/17/1991SE |
Questions and answers
When was Colorimetric Bun Reagent Kit cleared by the FDA?
Colorimetric Bun Reagent Kit (K871651) received a 510(k) decision of Substantially Equivalent on May 12, 1987, 14 days after the submission was received.
What is the product code of K871651?
The FDA product code is CDL – Berthelot Indophenol, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.