Wiener Lab. Ck-Nac UV Unitest, Wiener Lab. Ck-Nac UV Aa, Wiener Lab. Ck-Nac UV Aa, Wiener Lab.Nac UV Aa Liquida
FDA 510(k) K021332 · Wiener Laboratories Saic
510(k) numberK021332
Submission
- Device name
- Wiener Lab. Ck-Nac UV Unitest, Wiener Lab. Ck-Nac UV Aa, Wiener Lab. Ck-Nac UV Aa, Wiener Lab.Nac UV Aa Liquida
- Applicant
- Wiener Laboratories Saic
Rosario, Santa Fe, AR - Received
- April 26, 2002
- Decision date
- July 3, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGS – Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Specialty
- Clinical Chemistry
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| K160724 | ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorCGS · Traditional | Siemens Healthcare Diagnostics, Inc. | 09/07/2016SE |
| K123977 | Randox Liquid Ck-Mb, Randox Ck-Mb CalibratorCGS · Traditional | Randox Laboratories, Ltd. | 11/21/2013SE |
| K112416 | CPK ReagentCGS · Traditional | Vital Diagnostics (Manufacturing) Ptyltd | 11/09/2011SE |
| K083465 | Dimension Vista Creatine Kinase Flex Reagent Cartridge and Dimension Vista Creatine…CGS · Special | Siemens Healthcare Diagnostics | 02/27/2009SE |
| K081731 | Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge, and Cki/Mbi…CGS · Traditional | Siemens Healthcare Diagnostics | 08/29/2008SE |
| K072548 | Creatine Kinase Liquid Reagent, Model C519-440CGS · Traditional | Teco Diagnostics | 04/18/2008SE |
| K062737 | Cardiac Markers on Abx Pentra 400 Clinical Chemistry AnalyzerCGS · Traditional | Horiba Abx | 06/12/2007SE |
| K051648 | Spotchem II Inoganic Phosphorus, CPK and Uric Acid TestsCGS · Traditional | Arkray, Inc. | 01/31/2006SE |
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| 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 |
| 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 |
Questions and answers
When was Wiener Lab. Ck-Nac UV Unitest, Wiener Lab. Ck-Nac UV Aa, Wiener Lab. Ck-Nac UV Aa, Wiener Lab.Nac UV Aa Liquida cleared by the FDA?
Wiener Lab. Ck-Nac UV Unitest, Wiener Lab. Ck-Nac UV Aa, Wiener Lab. Ck-Nac UV Aa, Wiener Lab.Nac UV Aa Liquida (K021332) received a 510(k) decision of Substantially Equivalent on July 3, 2002, 68 days after the submission was received.
What is the product code of K021332?
The FDA product code is CGS – Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.