Enzymatic Alpha-Amylase Reagent Kit
FDA 510(k) K850639 · Bio-Analytics Laboratories, Inc.
510(k) numberK850639
Submission
- Device name
- Enzymatic Alpha-Amylase Reagent Kit
- Applicant
- Bio-Analytics Laboratories, Inc.
Palm City, FL, US - Received
- February 19, 1985
- Decision date
- March 5, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CIW – Starch-Dye Bound Polymer, Amylase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1070
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K931559 | Dma Amylase ProcedureCIW · Traditional | Data Medical Associates, Inc. | 10/28/1993SE |
| K924339 | Olympus Amylase ReagentCIW · Traditional | Olympus Corp. | 10/19/1992SE |
| K884382 | Amylase Test (Amyl) Item Number: 65653CIW · Traditional | Em Diagnostic Systems, Inc. | 01/11/1989SE |
| K812027 | Kodak Ektachem Clin. Chem. Slides (Amyl)CIW · Traditional | Eastman Kodak Company | 08/03/1981SE |
| K810584 | Phadebas Isoamylase TestCIW · Traditional | Pharmacia, Inc. | 05/13/1981SE |
| K810669 | Pantrak E.K.CIW · Traditional | Calbiochem-Behring Corp. | 03/31/1981SE |
| K782032 | Unitest AmylaseCIW · Traditional | Boehringer Mannheim Corp. | 03/02/1979SE |
More from Boehringer Mannheim Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K861638 | Kinetic Alkaline Phosphatase Reagent KitCJE · Traditional | 05/29/1986SE |
| 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 |
| 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 Enzymatic Alpha-Amylase Reagent Kit cleared by the FDA?
Enzymatic Alpha-Amylase Reagent Kit (K850639) received a 510(k) decision of Substantially Equivalent on March 5, 1985, 14 days after the submission was received.
What is the product code of K850639?
The FDA product code is CIW – Starch-Dye Bound Polymer, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.