Olympus Amylase Reagent
FDA 510(k) K944229 · Olympus America, Inc.
510(k) numberK944229
Submission
- Device name
- Olympus Amylase Reagent
- Applicant
- Olympus America, Inc.
Lake Success, NY, US - Received
- August 31, 1994
- Decision date
- December 9, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
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| K073490 | Olympus Igg ReagentCFN · Traditional | 02/11/2008SE |
| K073489 | Olympus Iga ReagentCFN · Traditional | 02/11/2008SE |
| K073487 | Olympus Igm ReagentCFN · Traditional | 02/11/2008SE |
| K062862 | Olympus Uric Acid Reagent, Model OSR6X98KNK · Traditional | 04/06/2007SE |
| K063804 | Olympus Triglyceride Test SystemCDT · Traditional | 03/23/2007SE |
| K061499 | OsferionMQV · Traditional | 01/26/2007SE |
| K062581 | Olympus TSH Reagent, Calibrator and Control and AU3000I Immunoassay SystemJLW · Traditional | 11/29/2006SE |
| K061575 | Olympus Calcium Arsenazo Reagent, OSR60117, OSR61117, OSR65117CJY · Traditional | 10/05/2006SE |
Questions and answers
When was Olympus Amylase Reagent cleared by the FDA?
Olympus Amylase Reagent (K944229) received a 510(k) decision of Substantially Equivalent on December 9, 1994, 100 days after the submission was received.
What is the product code of K944229?
The FDA product code is JFJ – Catalytic Methods, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.