Stanbio Enzymatic Urea Nitrogen Determinat #2010
FDA 510(k) K893128 · Stanbio Laboratory
510(k) numberK893128
Submission
- Device name
- Stanbio Enzymatic Urea Nitrogen Determinat #2010
- Applicant
- Stanbio Laboratory
San Antonio, TX, US - Received
- April 25, 1989
- Decision date
- July 25, 1989
- 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 |
| 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 |
| K801727 | Data-Zyme Urea Nitrogen, ColorimetricCDL · Traditional | Data Medical Associates, Inc. | 09/09/1980SE |
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| K032936 | Direct LDL Cholesterol Liquid Color and Stanbio Direct Hdl/Ldl Cholesterol CalibratorJIX · Traditional | 03/12/2004SE |
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Questions and answers
When was Stanbio Enzymatic Urea Nitrogen Determinat #2010 cleared by the FDA?
Stanbio Enzymatic Urea Nitrogen Determinat #2010 (K893128) received a 510(k) decision of Substantially Equivalent on July 25, 1989, 91 days after the submission was received.
What is the product code of K893128?
The FDA product code is CDL – Berthelot Indophenol, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.