Synchron Systems G7 Amylase (AMY7) Reagent with Model(S) A71607
FDA 510(k) K091846 · Beckman Coulter, Inc.
510(k) numberK091846
Submission
- Device name
- Synchron Systems G7 Amylase (AMY7) Reagent with Model(S) A71607
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- June 22, 2009
- Decision date
- October 16, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K040920 | Amylase Liquid Reagent, Model A532-200JFJ · Special | Teco Diagnostics | 05/10/2004SE |
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Questions and answers
When was Synchron Systems G7 Amylase (AMY7) Reagent with Model(S) A71607 cleared by the FDA?
Synchron Systems G7 Amylase (AMY7) Reagent with Model(S) A71607 (K091846) received a 510(k) decision of Substantially Equivalent on October 16, 2009, 116 days after the submission was received.
What is the product code of K091846?
The FDA product code is JFJ – Catalytic Methods, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.