Kinetic Alkaline Phosphatase Reagent Kit
FDA 510(k) K861638 · Bio-Analytics Laboratories, Inc.
510(k) numberK861638
Submission
- Device name
- Kinetic Alkaline Phosphatase Reagent Kit
- Applicant
- Bio-Analytics Laboratories, Inc.
Palm City, FL, US - Received
- April 30, 1986
- Decision date
- May 29, 1986
- 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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| 510(k) | Device | Decision |
|---|---|---|
| K860245 | Enzymatic Alpha-Amylase Reagent KitJFJ · Traditional | 03/14/1986SE |
| K860213 | Albumin Reagent KitCIX · Traditional | 02/11/1986SE |
| K851514 | Ultra-Violet Glucose ReagentCFA · Traditional | 05/20/1985SE |
| K851513 | Ultra-Violet Bun Reagent KitCDQ · Traditional | 05/20/1985SE |
| K850639 | Enzymatic Alpha-Amylase Reagent KitCIW · Traditional | 03/05/1985SE |
| K832771 | Erythrocyte TestLKZ · Traditional | 10/28/1983SE |
| K832567 | Acetaminophen(ParacetamolLDP · Traditional | 09/12/1983SE |
| K831414 | Colorimetric BunCDL · Traditional | 06/16/1983SE |
| K821934 | Bio-Cal Operation Check KitJIS · Traditional | 07/20/1982SE |
| K813431 | SalicylatesDKJ · Traditional | 03/25/1982SE |
Questions and answers
When was Kinetic Alkaline Phosphatase Reagent Kit cleared by the FDA?
Kinetic Alkaline Phosphatase Reagent Kit (K861638) received a 510(k) decision of Substantially Equivalent on May 29, 1986, 29 days after the submission was received.
What is the product code of K861638?
The FDA product code is CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.