Wiener Lab Amilasa 405 Aa Liquida
FDA 510(k) K023549 · Wiener Laboratories Saic
510(k) numberK023549
Submission
- Device name
- Wiener Lab Amilasa 405 Aa Liquida
- Applicant
- Wiener Laboratories Saic
Rosario, Santa Fe, AR - Received
- October 22, 2002
- Decision date
- December 9, 2002
- 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 |
|---|---|---|
| K023889 | Wiener Lab. Chagatest Elisa Recomninante V.3.0, Model 96 Tests Cat. Nr. 1203254MIU · Traditional | 02/11/2004SE |
| K024305 | Wiener Lab. Calibrator a Plus, Model 2X3 ML Cat. Nr. 1918006JIX · Traditional | 03/18/2003SE |
| K024116 | Wiener Lab. Bilirubina Direct AaCIG · Traditional | 02/12/2003SE |
| K023992 | Wiener Lab Colinesterasa AaDIH · Traditional | 02/12/2003SE |
| K023744 | Wiener Lab. Ck-Mb DS UV Unitest, Model 28 X 2.5 ML Cat. Nr. 1271354JHW · Traditional | 01/03/2003SE |
| K023551 | Wiener Lab Got (Ast) UV Aa LiquidaCIT · Traditional | 12/09/2002SE |
| K023550 | Wiener Lab Uricostat Enzimatico Aa LiquidaKNK · Traditional | 12/09/2002SE |
| K022962 | Wiener Lab. Bilirrubina Total AaCIG · Traditional | 11/01/2002SE |
| K021334 | Wiener Lab. Ca-Color Arsenazo III Aa, Model 4X50 ML Cat.Nr. 1152004, Wiener Lab.Ca-Color…CJY · Traditional | 09/10/2002SE |
| K021332 | Wiener Lab. Ck-Nac UV Unitest, Wiener Lab. Ck-Nac UV Aa, Wiener Lab. Ck-Nac UV Aa…CGS · Traditional | 07/03/2002SE |
Questions and answers
When was Wiener Lab Amilasa 405 Aa Liquida cleared by the FDA?
Wiener Lab Amilasa 405 Aa Liquida (K023549) received a 510(k) decision of Substantially Equivalent on December 9, 2002, 48 days after the submission was received.
What is the product code of K023549?
The FDA product code is JFJ – Catalytic Methods, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.