Ibl C3D-CIC Eia Test
FDA 510(k) K032796 · Ibl GmbH
510(k) numberK032796
Submission
- Device name
- Ibl C3D-CIC Eia Test
- Applicant
- Ibl GmbH
East Stroudsburg, PA, US - Received
- September 8, 2003
- Decision date
- January 13, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
|---|---|---|
| K051969 | Tricat Ria (Adrenalin/Noradrenalin/Dopamine); Katcombi Ria (Adrenalin/Noradrenalin)…CHQ · Traditional | 10/03/2005SE |
| K041349 | Luminescent Immunoassay Kit for the Detection of Estradiol in Saliva and SerumCHP · Traditional | 09/24/2004SE |
| K040923 | Luminescent Immunoassay Kit for the Detection of Progesterone in SalivaJLS · Traditional | 07/22/2004SE |
| K033786 | Luminescent Immunoassay Kit for the Detection of Testosterone in Serum and SalivaJIT · Traditional | 02/27/2004SE |
| K032254 | Ibl C1Q-CIC Cia TestDAK · Traditional | 08/29/2003SE |
Questions and answers
When was Ibl C3D-CIC Eia Test cleared by the FDA?
Ibl C3D-CIC Eia Test (K032796) received a 510(k) decision of Substantially Equivalent on January 13, 2004, 127 days after the submission was received.
What is the product code of K032796?
The FDA product code is CZW – Complement C3, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.