Amylase-Incorporating Dynamic Stabilization Technology - (DST)
FDA 510(k) K972297 · Trace America, Inc.
510(k) numberK972297
Submission
- Device name
- Amylase-Incorporating Dynamic Stabilization Technology - (DST)
- Applicant
- Trace America, Inc.
Miami, FL, US - Received
- June 19, 1997
- Decision date
- July 17, 1997
- 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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| 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 |
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| 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 |
|---|---|---|
| K003583 | Lithium Regent Model TR66056 / Lithium Standard TR66901NDW · Traditional | 01/17/2001SE |
| K980026 | Glucose (HK) - Incorporating Dynamic Stabilization Technology - (DST)CFR · Traditional | 03/10/1998SE |
| K980028 | Alt (GPT) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST)CKA · Traditional | 02/02/1998SE |
| K980030 | Ast )Got) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST)CIT · Traditional | 01/30/1998SE |
| K973869 | Trace Reagent Line for the Cobas MiraCKA · Traditional | 01/07/1998SE |
| K974620 | Ammonia-Incorporating Dynamic Stabilization Technology (DST)JIF · Traditional | 01/02/1998SE |
| K971485 | Uric Acid - Incorporating Dynamic Stabilization Technology - (DST)CDO · Traditional | 05/27/1997SE |
| K971477 | Urea (Urea Nitrogen) - Incorporating Dynamic Stabilization Technology (DST)CDQ · Traditional | 05/27/1997SE |
| K962723 | Trace HDL Cholesterol - Automated (HomogenLBR · Traditional | 03/13/1997SE |
| K961984 | Porphobilinogen (PBG)JNF · Traditional | 12/10/1996SE |
Questions and answers
When was Amylase-Incorporating Dynamic Stabilization Technology - (DST) cleared by the FDA?
Amylase-Incorporating Dynamic Stabilization Technology - (DST) (K972297) received a 510(k) decision of Substantially Equivalent on July 17, 1997, 28 days after the submission was received.
What is the product code of K972297?
The FDA product code is JFJ – Catalytic Methods, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.