FDA Product Code
FDA Product Code CZW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5240
510(k) Clearances — 44 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K100179 | SPAPLUS | The Binding Site Group , Ltd. | 2010-08-13 | Traditional | PDF ↗ |
| K063150 | COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL | Thermo Electron OY | 2007-03-19 | Traditional | PDF ↗ |
| K061852 | DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH | Dade Behring, Inc. | 2006-09-22 | Traditional | PDF ↗ |
| K050665 | N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) | Dade Behring, Inc. | 2005-05-02 | Traditional | PDF ↗ |
| K042494 | VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III | Ortho-Clinical Diagnostics | 2004-10-19 | Traditional | PDF ↗ |
| K032796 | IBL C3D-CIC EIA TEST | Ibl GmbH | 2004-01-13 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K012361 | TINA-QUANT COMPLEMENT C3C TEST SYSTEM | Roche Diagnostics Corp. | 2001-11-29 | Traditional | PDF ↗ |
| K010326 | WAKO AUTOKIT C3 | Wako Chemicals USA, Inc. | 2001-06-25 | Traditional | PDF ↗ |
| K000469 | RANDOX COMPLEMENT C3 | Randox Laboratories, Ltd. | 2000-03-27 | Traditional | PDF ↗ |
| K994296 | DIMENSION C3 FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2000-03-01 | Traditional | PDF ↗ |
| K981783 | C3 MININEPH ANTISERUM | The Binding Site, Ltd. | 1999-12-20 | Traditional | PDF ↗ |
| K993437 | K-ASSAY C3 | Kamiya Biomedical Co. | 1999-11-24 | Traditional | PDF ↗ |
| K991907 | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM | Bayer Corp. | 1999-11-09 | Traditional | PDF ↗ |
| K983441 | C3 | Abbott Laboratories | 1998-11-04 | Traditional | PDF ↗ |
| K964298 | N-ASSAY TIA MULTI V-NL | Crestat Diagnostics, Inc. | 1997-07-14 | Traditional | PDF ↗ |
| K964842 | IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT | Beckman Instruments, Inc. | 1997-06-11 | Traditional | PDF ↗ |
| K962409 | OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT | Olympus America, Inc. | 1996-10-18 | Traditional | PDF ↗ |
| K962199 | QUANTEX C3 | Instrumentation Laboratory CO | 1996-09-25 | Traditional | PDF ↗ |
| K955857 | N PROTEIN STANDARS SY | Behring Diagnostics, Inc. | 1996-02-21 | Traditional | PDF ↗ |
| K952594 | N PROTEIN STANDARD SY | Behring Diagnostics, Inc. | 1995-07-17 | Traditional | PDF ↗ |
| K920007 | IL TEST COMPLEMENT 3 | Instrumentation Laboratory CO | 1992-06-16 | Traditional | PDF ↗ |
| K911900 | RAICHEM SPIA C3 REAGENT | Reagents Applications, Inc. | 1991-05-09 | Traditional | PDF ↗ |
| K902382 | C3C AND C4 RID KITS | The Binding Site, Ltd. | 1990-09-07 | Traditional | PDF ↗ |
| K892127 | EZ COMPLEMENT C3 | Diamedix Corp. | 1989-04-14 | Traditional | PDF ↗ |
| K892125 | EZ COMPLEMENT C2 | Diamedix Corp. | 1989-04-14 | Traditional | PDF ↗ |
| K890675 | THE TURBOX ANALYSER SYSTEM COMPLEMENT C3 AND C4 | Unipath , Ltd. | 1989-03-06 | Traditional | PDF ↗ |
| K871939 | QM300 C3 ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-06-12 | Traditional | PDF ↗ |
| K871024 | PRECIMAT(R) C3 | Boehringer Mannheim Corp. | 1987-05-15 | Traditional | PDF ↗ |
| K871346 | DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY | Dako Corp. | 1987-04-21 | Traditional | PDF ↗ |
| K861362 | IMMUNOMEDICS SERUM ELISA TEST SYSTEM | Immunomedics, Inc. | 1986-06-06 | Traditional | PDF ↗ |
| K853466 | GILFORD C3 COMPLEMENT REAGENT | Gilford | 1985-09-16 | Traditional | PDF ↗ |
| K851286 | RADIAL IMMUNODIFFUSION PLATES C3 & C4 | Cooper Biomedical, Inc. | 1985-06-05 | Traditional | PDF ↗ |
| K850588 | SPQ TEST SYSTEM FOR COMPLEMENT C3 | Applications Lab | 1985-03-05 | Traditional | PDF ↗ |
| K834604 | C3 ANTISERUM CONTROL | Technicon Instruments Corp. | 1984-01-24 | Traditional | PDF ↗ |
| K831905 | RABBITT ANTISERUM TO HUMAN C3C | Dako Corp. | 1983-07-18 | Traditional | PDF ↗ |
| K830668 | FIAX COMPLEMENT C3 TEST KIT | Intl. Diagnostic Technology | 1983-04-05 | Traditional | PDF ↗ |
| K812491 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-C3 | Dako Corp. | 1981-09-23 | Traditional | PDF ↗ |
| K810501 | SCRIPPSYSTEM C3 RID KIT | Scripps-Miles, Inc. | 1981-04-08 | Traditional | PDF ↗ |
| K801363 | COMPLEMENT C3 NEPHELOMETRIC ASSAY | J.T. Baker Chemical Co. | 1980-06-30 | Traditional | PDF ↗ |
| K800212 | COMPLEMENT C3 REAGENT SYSTEM | Calbiochem-Behring Corp. | 1980-02-19 | Traditional | PDF ↗ |
| K791404 | LANCER L-INA ANTI-C3 | Sherwood Medical Co. | 1979-10-17 | Traditional | PDF ↗ |
| K781653 | NEPHELRATE ANTISERUMS C3C | Antibodies, Inc. | 1978-11-08 | Traditional | PDF ↗ |
| K760148 | SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN | Oxford Laboratories, Inc. | 1976-07-20 | Traditional | PDF ↗ |
Product code CZW · Class II · Immunology. Data: openFDA.