Wiener Lab. Amilasa 405 Cinetica Aa, Wiener Lab.Amilasa 405 Cinetica Unitest,Wiener Lab.Amilasa Cinetica Aa
FDA 510(k) K013101 · Wiener Laboratories Saic
510(k) numberK013101
Submission
- Device name
- Wiener Lab. Amilasa 405 Cinetica Aa, Wiener Lab.Amilasa 405 Cinetica Unitest,Wiener Lab.Amilasa Cinetica Aa
- Applicant
- Wiener Laboratories Saic
Rosario, Santa Fe, AR - Received
- September 17, 2001
- Decision date
- November 16, 2001
- 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
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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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Questions and answers
When was Wiener Lab. Amilasa 405 Cinetica Aa, Wiener Lab.Amilasa 405 Cinetica Unitest,Wiener Lab.Amilasa Cinetica Aa cleared by the FDA?
Wiener Lab. Amilasa 405 Cinetica Aa, Wiener Lab.Amilasa 405 Cinetica Unitest,Wiener Lab.Amilasa Cinetica Aa (K013101) received a 510(k) decision of Substantially Equivalent on November 16, 2001, 60 days after the submission was received.
What is the product code of K013101?
The FDA product code is JFJ – Catalytic Methods, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.