Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems Complement C4 (C4) Reagent, Synchron LX Systems Cali
FDA 510(k) K032035 · Beckman Coulter, Inc.
510(k) numberK032035
Submission
- Device name
- Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems Complement C4 (C4) Reagent, Synchron LX Systems Cali
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- July 1, 2003
- Decision date
- August 7, 2003
- 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
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|---|---|---|---|
| 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 |
| 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 |
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Questions and answers
When was Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems Complement C4 (C4) Reagent, Synchron LX Systems Cali cleared by the FDA?
Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems Complement C4 (C4) Reagent, Synchron LX Systems Cali (K032035) received a 510(k) decision of Substantially Equivalent on August 7, 2003, 37 days after the submission was received.
What is the product code of K032035?
The FDA product code is CZW – Complement C3, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.