DBA — Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control Class II
FDA product code DBA covers "Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5250. Submissions are reviewed by the Immunology panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DBA
- Device Class
- Class II
- Regulation Number
- 866.5250
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K141100 | binding site group | OPTILITE C1 INACTIVATOR KIT | July 18, 2014 |
| K122304 | binding site group | HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS | April 15, 2013 |
| K072965 | dade behring | DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON | December 21, 2007 |
| K011780 | kamiya biomedical | K-ASSAY C1-INA | July 25, 2001 |
| K003747 | baxter healthcare | C1-INHIBITOR MICROTITER ASSAY DEVICE | March 19, 2001 |
| K965024 | crestat diagnostics | N-ASSAY TIA C1-INACTIVATOR TEST KIT | July 14, 1997 |
| K960257 | behring diagnostics | N ANTISERUM TO C1 INHIBITOR | August 1, 1996 |
| K951967 | kent laboratories | HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT | May 30, 1995 |
| K915431 | binding site | COMPLEMENT C1 INACTIVATOR KIT | January 17, 1992 |
| K872426 | cytotech | CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY | July 23, 1987 |
| K821898 | ortho diagnostic systems | ORTHO CLASSICAL PATHWAY COMPL. TEST | July 16, 1982 |
| K781017 | icl scientific | ANTI-HUMAN C1 INHIBITOR SERUM (GOAT) | August 14, 1978 |
| K780335 | hyland therapeutic div., travenol laboratories | LAS-R HUMAN C1 ESTERASE INHIBITOR TEST | March 22, 1978 |