Additional Ims Assays for the Bayer Advia Ims System
FDA 510(k) K991907 · Bayer Corp.
510(k) numberK991907
Submission
- Device name
- Additional Ims Assays for the Bayer Advia Ims System
- Applicant
- Bayer Corp.
Tarrytown, NY, US - Received
- June 7, 1999
- Decision date
- November 9, 1999
- 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 |
| K010326 | Wako Autokit C3CZW · Traditional | Wako Chemicals USA, Inc. | 06/25/2001SE |
| K000469 | Randox Complement C3CZW · Traditional | Randox Laboratories, Ltd. | 03/27/2000SE |
More from Randox Laboratories, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K024062 | Ascensia Breeze Blood Glucose MeterCGA · Traditional | 03/03/2003SE |
| K023944 | Bayer Diagnostics Clinitest Pregnancy TestJHI · Abbreviated | 02/11/2003SE |
| K024017 | Bayer Advia Centaur HER-2/NEU AssayNCW · Traditional | 01/30/2003SE |
| K024234 | Ascensia Glucofacts; Ascensia Glucofacts ProfessionalNBW · Traditional | 01/23/2003SE |
| K022288 | Complexed Prostate Specific Antigen (Cpsa) Assay for the Bayer Advia Integrated Module…LTJ · Traditional | 12/17/2002SE |
| K023584 | Ascensia Dex 2 Diabetes Care SystemNBW · Special | 11/20/2002SE |
| K020828 | Ca 125 Assay for the Advia Centaur SystemLTK · Traditional | 07/24/2002SE |
| K021428 | Clinitek Atlas Pro 12 Reagent Pak SystemJFY · Traditional | 07/05/2002SE |
| K020806 | ACS:180 & Advia Centaur Afp ImmunoassayLOJ · Special | 03/27/2002SE |
| K013568 | Cea Assay for the Advia Integrated Modular SystemDHX · Traditional | 12/21/2001SE |
Questions and answers
When was Additional Ims Assays for the Bayer Advia Ims System cleared by the FDA?
Additional Ims Assays for the Bayer Advia Ims System (K991907) received a 510(k) decision of Substantially Equivalent on November 9, 1999, 155 days after the submission was received.
What is the product code of K991907?
The FDA product code is CZW – Complement C3, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.