Wako Autokit C3
FDA 510(k) K010326 · Wako Chemicals USA, Inc.
510(k) numberK010326
Submission
- Device name
- Wako Autokit C3
- Applicant
- Wako Chemicals USA, Inc.
Richmond, VA, US - Received
- February 2, 2001
- Decision date
- June 25, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CZW – Complement C3, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5240
- Specialty
- Immunology
Other 510(k)s with product code CZW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K100179 | SpaplusCZW · Traditional | The Binding Site Group , Ltd. | 08/13/2010SE |
| K063150 | Complement C3 and C4, Specical Calibrator and Specitrol Control and High ControlCZW · Traditional | Thermo Electron OY | 03/19/2007SE |
| K061852 | Dimension Vista C3 and C4 Flex Reagent Cartridge, Protein 1 Calibrator, Control Low…CZW · Traditional | Dade Behring, Inc. | 09/22/2006SE |
| K050665 | N Antisera to Human Complement Factors (C3C, C4)CZW · Traditional | Dade Behring, Inc. | 05/02/2005SE |
| K042494 | Vitros Chemistry Products C3 and CR Reagent, Calibrator Kit 20, Protein Performance…CZW · Traditional | Ortho-Clinical Diagnostics | 10/19/2004SE |
| K032796 | Ibl C3D-CIC Eia TestCZW · Traditional | Ibl GmbH | 01/13/2004SE |
| K032035 | Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems Complement C4 (C4)…CZW · Traditional | Beckman Coulter, Inc. | 08/07/2003SE |
| K012361 | Tina-Quant Complement C3C Test SystemCZW · Traditional | Roche Diagnostics Corp. | 11/29/2001SE |
| K000469 | Randox Complement C3CZW · Traditional | Randox Laboratories, Ltd. | 03/27/2000SE |
| K994296 | Dimension C3 Flex Reagent CartridgeCZW · Traditional | Dade Behring, Inc. | 03/01/2000SE |
More from Dade Behring, Inc.
| 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 Autokit C3 cleared by the FDA?
Wako Autokit C3 (K010326) received a 510(k) decision of Substantially Equivalent on June 25, 2001, 143 days after the submission was received.
What is the product code of K010326?
The FDA product code is CZW – Complement C3, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.