Enzymatic Alpha-Amylase Reagent Kit
FDA 510(k) K860245 · Bio-Analytics Laboratories, Inc.
510(k) numberK860245
Submission
- Device name
- Enzymatic Alpha-Amylase Reagent Kit
- Applicant
- Bio-Analytics Laboratories, Inc.
Palm City, FL, US - Received
- January 24, 1986
- Decision date
- March 14, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JFJ – Catalytic Methods, Amylase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1070
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K210633 | Amylase2JFJ · Traditional | Abbott Ireland Diagnostics Division | 05/26/2022SE |
| K191454 | Atellica CH Amylase_2 (AMY_2)JFJ · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/30/2019SE |
| K182474 | alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT…JFJ · Traditional | Biosystems S.A. | 05/02/2019SE |
| K130685 | Hitachi Clinical Analyzer S Test Reagent Cartridges for LD and AmyJFJ · Traditional | Hitachi Chemical Diagnostics, Inc. | 08/09/2013SE |
| K122858 | Eltech Chinical System Amylase SL Elitech Clinical Systems ELICAL2 Eltech Clinical…JFJ · Traditional | Elitechgroup | 10/03/2012SE |
| K091846 | Synchron Systems G7 Amylase (AMY7) Reagent with Model(S) A71607JFJ · Traditional | Beckman Coulter, Inc. | 10/16/2009SE |
| K080823 | Easyra Amylase, Bun, Glu-H, Trig, Uric ReagentJFJ · Traditional | Medica Corp. | 11/17/2008SE |
| K070064 | Amylase Eps ReagentJFJ · Traditional | Thermo Fisher Scientific | 05/22/2007SE |
| K062180 | Abx Pentra Amylase CP; Multical; N Control; P Control; Clean-Chem CP; Clean-Chem 99 CPJFJ · Traditional | Horiba Abx | 10/02/2006SE |
| K051447 | Sentinel Pancreatic AmylaseJFJ · Traditional | Sentinel Ch. Srl | 01/26/2006SE |
More from Sentinel Ch. Srl
| 510(k) | Device | Decision |
|---|---|---|
| K861638 | Kinetic Alkaline Phosphatase Reagent KitCJE · Traditional | 05/29/1986SE |
| 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 Enzymatic Alpha-Amylase Reagent Kit cleared by the FDA?
Enzymatic Alpha-Amylase Reagent Kit (K860245) received a 510(k) decision of Substantially Equivalent on March 14, 1986, 49 days after the submission was received.
What is the product code of K860245?
The FDA product code is JFJ – Catalytic Methods, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.