Dimension Vista C3 and C4 Flex Reagent Cartridge, Protein 1 Calibrator, Control Low, Medium, High
FDA 510(k) K061852 · Dade Behring, Inc.
510(k) numberK061852
Submission
- Device name
- Dimension Vista C3 and C4 Flex Reagent Cartridge, Protein 1 Calibrator, Control Low, Medium, High
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- June 30, 2006
- Decision date
- September 22, 2006
- 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 |
| 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 |
| K010326 | Wako Autokit C3CZW · Traditional | Wako Chemicals USA, Inc. | 06/25/2001SE |
| 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 |
|---|---|---|
| K093848 | Pt-Multi-Calibrator, Model OPAT07GGN · Traditional | 12/20/2010SE |
| K081161 | Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1…CFN · Traditional | 07/28/2008SE |
| K081249 | Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1…DEB · Traditional | 07/21/2008SE |
| K071603 | Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)DHX · Traditional | 06/25/2008SE |
| K071597 | Dimension Vista (R) Afp Flex(R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci…LOJ · Traditional | 06/04/2008SE |
| K073604 | Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent Cartridge…CEC · Traditional | 03/13/2008SE |
| K073561 | Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…CFN · Traditional | 02/26/2008SE |
| K073072 | Dimension Ahdl Flex Reagent Cartridge, Model: DF48BJHM · Traditional | 02/21/2008SE |
| K073055 | Dimension Enzymatic Creatinine Flex Reagent Cartridge with Model DF270JFY · Traditional | 01/03/2008SE |
| K072965 | Dimension Vista C1 in; Flex Reagent Cartridge, Cal, ConDBA · Traditional | 12/21/2007SE |
Questions and answers
When was Dimension Vista C3 and C4 Flex Reagent Cartridge, Protein 1 Calibrator, Control Low, Medium, High cleared by the FDA?
Dimension Vista C3 and C4 Flex Reagent Cartridge, Protein 1 Calibrator, Control Low, Medium, High (K061852) received a 510(k) decision of Substantially Equivalent on September 22, 2006, 84 days after the submission was received.
What is the product code of K061852?
The FDA product code is CZW – Complement C3, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.