Amylase
FDA 510(k) K930678 · Horizon Diagnostics, Inc.
510(k) numberK930678
Submission
- Device name
- Amylase
- Applicant
- Horizon Diagnostics, Inc.
Ann Arbor, MI, US - Received
- February 9, 1993
- Decision date
- April 6, 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
Other 510(k)s with product code JFJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K971566 | Creatine Kinase-Mb Reagent SetCGS · Traditional | 07/14/1997SE |
| K933722 | Horizon Diagnostics Triglycerides-Gpo ReagentCDT · Traditional | 06/13/1996SE |
| K935712 | Iron/Tibc ReagentJIY · Traditional | 09/20/1995SE |
| K934533 | BUN-300/BUN-500 Urea Nitrogen ReagentCDQ · Traditional | 11/26/1993SE |
| K930679 | Direct BilirubinCIG · Traditional | 06/29/1993SE |
| K930074 | In-Vitro Diagnostic Reagent SetJGJ · Traditional | 05/11/1993SE |
Questions and answers
When was Amylase cleared by the FDA?
Amylase (K930678) received a 510(k) decision of Substantially Equivalent on April 6, 1994, 421 days after the submission was received.
What is the product code of K930678?
The FDA product code is JFJ – Catalytic Methods, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.