Wiener Lab Uricostat Enzimatico Aa Liquida
FDA 510(k) K023550 · Wiener Laboratories Saic
510(k) numberK023550
Submission
- Device name
- Wiener Lab Uricostat Enzimatico 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
- KNK – Acid, Uric, Uricase (Colorimetric)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1775
- Specialty
- Clinical Chemistry
Other 510(k)s with product code KNK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K102568 | Uric Acid Model 3P39KNK · Traditional | Abbott Laboratories | 05/06/2011SE |
| K062862 | Olympus Uric Acid Reagent, Model OSR6X98KNK · Traditional | Olympus America, Inc. | 04/06/2007SE |
| K040467 | Vitalab Uric Acid ReagentKNK · Traditional | Clinical Data, Inc. | 03/08/2004SE |
| K031044 | Atac Pak Uric Acid Reagent and Atac CalibratorKNK · Traditional | Clinical Data, Inc. | 07/15/2003SE |
| K022096 | Uric Acid Assay for the Advia Integrated Modular SystemKNK · Traditional | Bayer Diagnostics Corp. | 03/18/2003SE |
| K012038 | Jas Uric Acid Liquid ReagentKNK · Traditional | Jas Diagnostics, Inc. | 08/21/2001SE |
| K010421 | Wiener Lab. Uricostat Enzimatico Aa, Models 2X50 ML Catalogue No 1840106 and 4X50 ML…KNK · Traditional | Wiener Laboratories Saic | 04/13/2001SE |
| K993469 | Wako L-Type Ua F TestKNK · Traditional | Wako Chemicals USA, Inc. | 11/09/1999SE |
| K991247 | Uric Acid, Model UA112-01KNK · Traditional | A.P. Total Care, Inc. | 05/25/1999SE |
| K981604 | Careside Uric AcidKNK · Traditional | Careside, Inc. | 06/25/1998SE |
More from Careside, Inc.
| 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 |
| K023549 | Wiener Lab Amilasa 405 Aa LiquidaJFJ · 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 Uricostat Enzimatico Aa Liquida cleared by the FDA?
Wiener Lab Uricostat Enzimatico Aa Liquida (K023550) 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 K023550?
The FDA product code is KNK – Acid, Uric, Uricase (Colorimetric), a Class I (low risk) device regulated under 21 CFR 862.1775.