Product code CZW
- Device name
- Complement C3, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5240
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K100179 | SPAPLUS | The Binding Site Group , Ltd. | 2010-08-13 |
| K063150 | COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL | Thermo Electron OY | 2007-03-19 |
| K061852 | DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH | Dade Behring, Inc. | 2006-09-22 |
| K050665 | N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) | Dade Behring, Inc. | 2005-05-02 |
| K042494 | VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III | Ortho-Clinical Diagnostics | 2004-10-19 |
| K032796 | IBL C3D-CIC EIA TEST | Ibl GmbH | 2004-01-13 |
| K032035 | SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI | Beckman Coulter, Inc. | 2003-08-07 |
| K012361 | TINA-QUANT COMPLEMENT C3C TEST SYSTEM | Roche Diagnostics Corp. | 2001-11-29 |
| K010326 | WAKO AUTOKIT C3 | Wako Chemicals USA, Inc. | 2001-06-25 |
| K000469 | RANDOX COMPLEMENT C3 | Randox Laboratories, Ltd. | 2000-03-27 |
| K994296 | DIMENSION C3 FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2000-03-01 |
| K981783 | C3 MININEPH ANTISERUM | The Binding Site, Ltd. | 1999-12-20 |
| K993437 | K-ASSAY C3 | Kamiya Biomedical Co. | 1999-11-24 |
| K991907 | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM | Bayer Corp. | 1999-11-09 |
| K983441 | C3 | Abbott Laboratories | 1998-11-04 |
| K964298 | N-ASSAY TIA MULTI V-NL | Crestat Diagnostics, Inc. | 1997-07-14 |
| K964842 | IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT | Beckman Instruments, Inc. | 1997-06-11 |
| K962409 | OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT | Olympus America, Inc. | 1996-10-18 |
| K962199 | QUANTEX C3 | Instrumentation Laboratory CO | 1996-09-25 |
| K955857 | N PROTEIN STANDARS SY | Behring Diagnostics, Inc. | 1996-02-21 |
| K952594 | N PROTEIN STANDARD SY | Behring Diagnostics, Inc. | 1995-07-17 |
| K920007 | IL TEST COMPLEMENT 3 | Instrumentation Laboratory CO | 1992-06-16 |
| K911900 | RAICHEM SPIA C3 REAGENT | Reagents Applications, Inc. | 1991-05-09 |
| K902382 | C3C AND C4 RID KITS | The Binding Site, Ltd. | 1990-09-07 |
| K892125 | EZ COMPLEMENT C2 | Diamedix Corp. | 1989-04-14 |
| K892127 | EZ COMPLEMENT C3 | Diamedix Corp. | 1989-04-14 |
| K890675 | THE TURBOX ANALYSER SYSTEM COMPLEMENT C3 AND C4 | Unipath , Ltd. | 1989-03-06 |
| K871939 | QM300 C3 ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-06-12 |
| K871024 | PRECIMAT(R) C3 | Boehringer Mannheim Corp. | 1987-05-15 |
| K871346 | DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY | Dako Corp. | 1987-04-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00380740170172 | Alinity | ABBOTT IRELAND | 2021-05-13 |
| 00380740170189 | ARCHITECT | ABBOTT IRELAND | 2021-03-26 |
| 00380740175153 | ARCHITECT | Abbott GmbH | 2020-11-06 |
| 07613336133590 | Tina-quant Complement C3c Ver.2 | Roche Diagnostics GmbH | 2020-03-05 |
| 00380740150662 | Alinity | Abbott GmbH | 2019-06-27 |
| 05051700010542 | Human Complement C3 ‘NL’ BINDARID™ Radial Immunodiffusion Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 00630414517735 | ADVIA® Chemistry C3 Complement C3 Reagents | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768009723 | N Antiserum to Human C3c | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768009716 | N Antiserum to Human C3c | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768006050 | Dimension Vista® C3 Complement Flex® reagent cartridge | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768005220 | Dimension® Flex® reagent cartridge C3 | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 05051700017596 | Optilite C3c Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700015578 | Human C3c Kit for use on the SPAplus | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700010559 | Human Complement C4 ‘NL’ BINDARID™ Radial Immunodiffusion Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| B1761190 | Antiserum to Human C-3 (b1c) | KENT LABORATORIES INC | 2016-09-24 |
| B1761052 | Anti Human C-3 (b1c/b1a) FITC | KENT LABORATORIES INC | 2016-09-24 |
| B1761050 | Antiserum to Human C-3 (b1c/b1a) | KENT LABORATORIES INC | 2016-09-24 |
| 15099590010560 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 04015630910274 | Tinaquant C3c | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630928422 | Tinaquant Complement C3c ver2 | Roche Diagnostics GmbH | 2016-09-20 |
| 00813545023829 | Scanlisa C3d Elisa 96 Test | SCIMEDX CORPORATION | 2016-09-20 |
| 00813545023836 | C3d Plates & Calibrator Sets | SCIMEDX CORPORATION | 2016-09-20 |
| 04015630917709 | Tinaquant Complement C3c ver2 | Roche Diagnostics GmbH | 2016-09-20 |
| 05055273201611 | C3 | RANDOX LABORATORIES LIMITED | 2016-09-16 |
| 05700572002482 | Poly Rb A-Hu C3c Complement/FITC | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | 2016-09-16 |
| 00816426020078 | K-ASSAY® Complement C3 Reagent | KAMIYA BIOMEDICAL COMPANY, LLC | 2016-09-16 |
| 00817302020922 | CAROLINA LIQUID CHEMISTRIES CORP.® C3 Complement C3 CC634 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 15099590230487 | IMMAGE | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590229733 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 10758750006847 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-23 |