DBI — Complement C4, Antigen, Antiserum, Control Class II
FDA Device Classification
Classification Details
- Product Code
- DBI
- 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 |
|---|
| K100455 | binding site | SPAPLUS ANALYZER | September 3, 2010 |
| K012359 | roche diagnostics | TINA-QUANT COMPLEMENT C4 TEST SYSTEM | November 29, 2001 |
| K010325 | wako chemicals usa | WAKO AUTOKIT C4 | June 25, 2001 |
| K000468 | randox laboratories | RANDOX COMPLEMENT C4 | March 27, 2000 |
| K994293 | dade behring | DIMENSION C4 FLEX REAGENT CARTRIDGE | March 1, 2000 |
| K981785 | binding site | C4 MININEPH ANTISERUM | December 20, 1999 |
| K993481 | kamiya biomedical | K-ASSAY C4 | November 29, 1999 |
| K983356 | abbott laboratories | C4 | November 4, 1998 |
| K964297 | crestat diagnostics | N-ASSAY TIA C4 TEST KIT | July 14, 1997 |
| K964300 | crestat diagnostics | N-ASSAY TIA MULTI V-NL | July 14, 1997 |
| K962582 | olympus america | OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT | October 18, 1996 |
| K962198 | instrumentation laboratory | QUANTEX C4 | September 26, 1996 |
| K920010 | instrumentation laboratory | IL TEST COMPLEMENT 4 | March 13, 1992 |
| K911899 | reagents applications | RAICHEM SPIA C4 REAGENT | May 9, 1991 |
| K892129 | diamedix | EZ COMPLEMENT C4 | April 14, 1989 |
| K890564 | atlantic antibodies | SPQ(TM) ANTIBODY REAGENT SET II FOR C4 | February 17, 1989 |
| K882621 | technicon instruments | COMPLEMENT C4 FOR THE TECHNICON DPA-1(TM) SYSTEM | July 8, 1988 |
| K872599 | kallestad diag, a div. of erbamont | QM300 C4 ANTIBODY PACK | July 23, 1987 |
| K871023 | boehringer mannheim | PRECIMAT(R) C4 | May 14, 1987 |
| K870931 | boehringer mannheim | TINA-QUANT(R) (A) C4 | March 24, 1987 |