Product code DBI
- Device name
- Complement C4, 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 |
|---|---|---|---|
| K100455 | SPAPLUS ANALYZER | The Binding Site | 2010-09-03 |
| K012359 | TINA-QUANT COMPLEMENT C4 TEST SYSTEM | Roche Diagnostics Corp. | 2001-11-29 |
| K010325 | WAKO AUTOKIT C4 | Wako Chemicals USA, Inc. | 2001-06-25 |
| K000468 | RANDOX COMPLEMENT C4 | Randox Laboratories, Ltd. | 2000-03-27 |
| K994293 | DIMENSION C4 FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2000-03-01 |
| K981785 | C4 MININEPH ANTISERUM | The Binding Site, Ltd. | 1999-12-20 |
| K993481 | K-ASSAY C4 | Kamiya Biomedical Co. | 1999-11-29 |
| K983356 | C4 | Abbott Laboratories | 1998-11-04 |
| K964300 | N-ASSAY TIA MULTI V-NL | Crestat Diagnostics, Inc. | 1997-07-14 |
| K964297 | N-ASSAY TIA C4 TEST KIT | Crestat Diagnostics, Inc. | 1997-07-14 |
| K962582 | OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | 1996-10-18 |
| K962198 | QUANTEX C4 | Instrumentation Laboratory CO | 1996-09-26 |
| K920010 | IL TEST COMPLEMENT 4 | Instrumentation Laboratory CO | 1992-03-13 |
| K911899 | RAICHEM SPIA C4 REAGENT | Reagents Applications, Inc. | 1991-05-09 |
| K892129 | EZ COMPLEMENT C4 | Diamedix Corp. | 1989-04-14 |
| K890564 | SPQ(TM) ANTIBODY REAGENT SET II FOR C4 | Atlantic Antibodies | 1989-02-17 |
| K882621 | COMPLEMENT C4 FOR THE TECHNICON DPA-1(TM) SYSTEM | Technicon Instruments Corp. | 1988-07-08 |
| K872599 | QM300 C4 ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-07-23 |
| K871023 | PRECIMAT(R) C4 | Boehringer Mannheim Corp. | 1987-05-14 |
| K870931 | TINA-QUANT(R) (A) C4 | Boehringer Mannheim Corp. | 1987-03-24 |
| K855012 | QUANTIMETRIC PLUS C4 REAGENT KIT | Kallestad Laboratories, Inc. | 1986-02-26 |
| K853468 | GILFORD C4 COMPLEMENT REAGENT | Gilford | 1985-09-16 |
| K850585 | SPQ TEST SYSTEM FOR COMPLEMENT C4 | Applications Lab | 1985-03-01 |
| K834605 | C4 ANTIGEN ANTIBODY CONTROL | Technicon Instruments Corp. | 1984-01-24 |
| K831906 | RABBIT ANTISERUM TO HUMAN C4 | Dako Corp. | 1983-07-19 |
| K830669 | FIAX COMPLEMENT C4 TEST KIT | Intl. Diagnostic Technology | 1983-04-08 |
| K812490 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-C4 | Dako Corp. | 1981-09-23 |
| K810502 | SCRIPPSYSTEM C4 RID KIT | Scripps-Miles, Inc. | 1981-04-08 |
| K802196 | GOAT ANTI-HUMAN COMPLEMENT C4 | Protos Laboratories | 1980-10-31 |
| K801361 | COMPLEMENT C4 NEPHELOMETRIC ASSAY | J.T. Baker Chemical Co. | 1980-06-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00380740170196 | Alinity | ABBOTT IRELAND | 2021-05-13 |
| 00380740170202 | ARCHITECT | ABBOTT IRELAND | 2021-03-19 |
| 00380740175160 | ARCHITECT | Abbott GmbH | 2020-11-06 |
| 07613336133606 | Tina-quant Complement C4 Ver.2 | Roche Diagnostics GmbH | 2020-03-05 |
| 00380740150679 | Alinity | Abbott GmbH | 2019-06-27 |
| 00630414595658 | Atellica CH C4 | Siemens Healthcare Diagnostics Inc. | 2017-12-27 |
| 00842768009709 | N Antiserum to Human C4 | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00630414517742 | ADVIA® Chemistry C4 Complement C4 Reagents | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 15099590010577 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 00842768009693 | N Antiserum to Human C4 | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768006067 | Dimension Vista® C4 Complement Flex® reagent cartridge | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| B1761090 | Antiserum to Human C-4 (b1e) | KENT LABORATORIES INC | 2016-09-24 |
| B1761092 | Anti Human Complement C4 (b1e) FITC | KENT LABORATORIES INC | 2016-09-24 |
| 05051700015585 | Human C4 Kit for use on SPAPLUS | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700017602 | Optilite C4 Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 00842768005237 | Dimension® Flex® reagent cartridge C4 | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 04015630917716 | Tinaquant Complement C4 ver2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630928460 | Tinaquant Complement C4 ver2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630910267 | Tinaquant C4 | Roche Diagnostics GmbH | 2016-09-20 |
| 05700572002420 | Poly Rb A-Hu C4c Complement/FITC | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | 2016-09-16 |
| 05055273201628 | C4 | RANDOX LABORATORIES LIMITED | 2016-09-16 |
| 00816426020085 | K-ASSAY® Complement C4 Reagent | KAMIYA BIOMEDICAL COMPANY, LLC | 2016-09-16 |
| 00817302020939 | CAROLINA LIQUID CHEMISTRIES CORP.® C4 Complement C4 CC635 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 15099590230449 | IMMAGE | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590229726 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 10758750006854 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-23 |
| 00380740019747 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |