Vitros Chemistry Products C3 and CR Reagent, Calibrator Kit 20, Protein Performance Verifiers I, II, and III
FDA 510(k) K042494 · Ortho-Clinical Diagnostics
510(k) numberK042494
Submission
- Device name
- Vitros Chemistry Products C3 and CR Reagent, Calibrator Kit 20, Protein Performance Verifiers I, II, and III
- Applicant
- Ortho-Clinical Diagnostics
Rochester, NY, US - Received
- September 14, 2004
- Decision date
- October 19, 2004
- 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 |
| 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 |
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Questions and answers
When was Vitros Chemistry Products C3 and CR Reagent, Calibrator Kit 20, Protein Performance Verifiers I, II, and III cleared by the FDA?
Vitros Chemistry Products C3 and CR Reagent, Calibrator Kit 20, Protein Performance Verifiers I, II, and III (K042494) received a 510(k) decision of Substantially Equivalent on October 19, 2004, 35 days after the submission was received.
What is the product code of K042494?
The FDA product code is CZW – Complement C3, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.