DBI — Complement C4, Antigen, Antiserum, Control Class II
FDA product code DBI covers "Complement C4, 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
- 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 |
| K964300 | crestat diagnostics | N-ASSAY TIA MULTI V-NL | July 14, 1997 |
| K964297 | crestat diagnostics | N-ASSAY TIA C4 TEST KIT | 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 |