DAK — Complement C1q, Antigen, Antiserum, Control Class II
FDA Device Classification
Classification Details
- Product Code
- DAK
- 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 |
|---|
| K031563 | binding site | BINDAZYME CLQ CIC EIA KIT | September 10, 2003 |
| K032254 | ibl | IBL C1Q-CIC CIA TEST | August 29, 2003 |
| K012576 | american laboratory products co | CIC-C1Q EIA | January 29, 2002 |
| K973203 | sangstat medical | THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODI | September 30, 1998 |
| K972873 | immunomedics | IMMUSTRIP HAMA IGG | March 17, 1998 |
| K951968 | kent laboratories | HUMAN C1Q RADIAL IMMUNODIFFUSION KIT | May 30, 1995 |
| K914388 | binding site | C1 RID KIT | October 28, 1991 |
| K882829 | cytotech | CIRCULATING IMMUNE COMPLEXES CONTROLS | August 4, 1988 |
| K860996 | scientific sales intl | SANASSAY IC TEST | March 30, 1987 |
| K864312 | diamedix | IC MICROASSAY | January 9, 1987 |
| K862649 | cytotech | CYTOTECH CIC ENZYME IMMUNOASSAY | September 4, 1986 |
| K861499 | biostar medical products | BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT | June 20, 1986 |
| K853697 | biostar medical products | BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT | December 16, 1985 |
| K851202 | gilford | GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL | April 29, 1985 |
| K844294 | cordis | CORDIA IC | February 4, 1985 |
| K833275 | gamma medical products | GMP CIQ ELISA TEST KIT | June 22, 1984 |
| K833636 | ortho diagnostic systems | ORTHO* SERUM ELISA TEST SYSTEM | June 13, 1984 |
| K841541 | collaborative research | SERUM COMPLEMENT ACTIVITY TEST-SCAT | June 1, 1984 |
| K823009 | gamma medical products | GAMMA CLQ | November 5, 1982 |
| K821949 | ortho diagnostic systems | ORTHO* ALTERNATIVE PATHWAY COMPL. TEST | August 27, 1982 |