Kinetic Alkaline Phosphatase Determination
FDA 510(k) K905650 · Biochemical Trade, Inc.
510(k) numberK905650
Submission
- Device name
- Kinetic Alkaline Phosphatase Determination
- Applicant
- Biochemical Trade, Inc.
Miami, FL, US - Received
- December 18, 1990
- Decision date
- February 13, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1050
- Specialty
- Clinical Chemistry
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More from Alfa Wassermann
| 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 |
| 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 |
| K871547 | Ultra-Violet Bun Reagent Kit (Rate)CDQ · Traditional | 06/22/1987SE |
Questions and answers
When was Kinetic Alkaline Phosphatase Determination cleared by the FDA?
Kinetic Alkaline Phosphatase Determination (K905650) received a 510(k) decision of Substantially Equivalent on February 13, 1991, 57 days after the submission was received.
What is the product code of K905650?
The FDA product code is CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.