DBA — Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control Class II
FDA Device Classification
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 |