DAK — Complement C1q, Antigen, Antiserum, Control Class II
FDA product code DAK covers "Complement C1q, 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
- 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 |