Urea Nitrogen Test Kit
FDA 510(k) K781306 · Analytical & Research Chemicals, Inc.
510(k) numberK781306
Submission
- Device name
- Urea Nitrogen Test Kit
- Applicant
- Analytical & Research Chemicals, Inc.
Mchenry, IL, US - Received
- July 28, 1978
- Decision date
- August 31, 1978
- 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 |
| 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 |
More from Volu Sol Medical Industries
| 510(k) | Device | Decision |
|---|---|---|
| K823806 | Direct Creatinine ProcedureCGX · Traditional | 01/14/1983SE |
| K823786 | Alkaline PhosphataseCJE · Traditional | 01/14/1983SE |
| K823784 | Enzymatic Cholesterol (ColorimetricCHH · Traditional | 01/14/1983SE |
| K781460 | Chloride ReagentCHJ · Traditional | 10/10/1978SE |
| K781441 | BCG Albumin ReagetCIX · Traditional | 10/10/1978SE |
| K781324 | Alp TestCIO · Traditional | 08/31/1978SE |
| K781323 | LDH Procedure · Traditional | 08/31/1978SE |
| K781309 | Got Procedure · Traditional | 08/31/1978SE |
| K781308 | GlucolourCGE · Traditional | 08/31/1978SE |
| K781307 | Glucose Determ. KitCGA · Traditional | 08/31/1978SE |
Questions and answers
When was Urea Nitrogen Test Kit cleared by the FDA?
Urea Nitrogen Test Kit (K781306) received a 510(k) decision of Substantially Equivalent on August 31, 1978, 34 days after the submission was received.
What is the product code of K781306?
The FDA product code is CDL – Berthelot Indophenol, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.