Wako L-Type Amylase
FDA 510(k) K984184 · Wako Chemicals USA, Inc.
510(k) numberK984184
Submission
- Device name
- Wako L-Type Amylase
- Applicant
- Wako Chemicals USA, Inc.
Richmond, VA, US - Received
- November 23, 1998
- Decision date
- January 13, 1999
- 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
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 |
|---|---|---|
| K100464 | Utaswako I30 (Includes Accessories), Utaswako AFP-L3, Calibrator Set, Control L, Control…NSF · Traditional | 02/23/2011SE |
| K080125 | Apolowako T-Cho, Hdl-C, TG and Analyzer, Models 993-23501, 999-23601, 995-23701 and…LBS · Traditional | 07/18/2008SE |
| K080123 | Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201CFR · Traditional | 07/17/2008SE |
| K061775 | Wako L-Type Creatinine-M Test, and Wako Creatinine CalibratorJFY · Traditional | 02/23/2007SE |
| K062368 | Wako Lba DCP Test System, Model 993-05301; DCP Control Set, Model 995-0551; DCP…OAU · Traditional | 01/31/2007SE |
| K053132 | Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791JFM · Traditional | 12/30/2005SE |
| K053131 | Wako Total Bilirubin V, Models 410-22701, 998-23291, 416-22801, 990-23191JFM · Traditional | 12/30/2005SE |
| K042551 | Multi-Chem Calibrator aJIX · Traditional | 11/16/2004SE |
| K042550 | Multi-Lipid CalibratorJIX · Traditional | 11/08/2004SE |
| K042549 | Multi Chem Cal BJIX · Traditional | 11/08/2004SE |
Questions and answers
When was Wako L-Type Amylase cleared by the FDA?
Wako L-Type Amylase (K984184) received a 510(k) decision of Substantially Equivalent on January 13, 1999, 51 days after the submission was received.
What is the product code of K984184?
The FDA product code is JFJ – Catalytic Methods, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.