CZW — Complement C3, Antigen, Antiserum, Control Class II
FDA product code CZW covers "Complement C3, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5240. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CZW
- Device Class
- Class II
- Regulation Number
- 866.5240
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K100179 | binding site group | SPAPLUS | August 13, 2010 |
| K063150 | thermo electron | COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL | March 19, 2007 |
| K061852 | dade behring | DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL | September 22, 2006 |
| K050665 | dade behring | N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) | May 2, 2005 |
| K042494 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMA | October 19, 2004 |
| K032796 | ibl | IBL C3D-CIC EIA TEST | January 13, 2004 |
| K032035 | beckman coulter | SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C | August 7, 2003 |
| K012361 | roche diagnostics | TINA-QUANT COMPLEMENT C3C TEST SYSTEM | November 29, 2001 |
| K010326 | wako chemicals usa | WAKO AUTOKIT C3 | June 25, 2001 |
| K000469 | randox laboratories | RANDOX COMPLEMENT C3 | March 27, 2000 |
| K994296 | dade behring | DIMENSION C3 FLEX REAGENT CARTRIDGE | March 1, 2000 |
| K981783 | binding site | C3 MININEPH ANTISERUM | December 20, 1999 |
| K993437 | kamiya biomedical | K-ASSAY C3 | November 24, 1999 |
| K991907 | bayer | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM | November 9, 1999 |
| K983441 | abbott laboratories | C3 | November 4, 1998 |
| K964298 | crestat diagnostics | N-ASSAY TIA MULTI V-NL | July 14, 1997 |
| K964842 | beckman instruments | IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT | June 11, 1997 |
| K962409 | olympus america | OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT | October 18, 1996 |
| K962199 | instrumentation laboratory | QUANTEX C3 | September 25, 1996 |
| K955857 | behring diagnostics | N PROTEIN STANDARS SY | February 21, 1996 |