CFQ — Radioimmunoassay, Immunoglobulins (G, A, M) Class II
FDA product code CFQ covers "Radioimmunoassay, Immunoglobulins (G, A, M)", a Class II medical device regulated under 21 CFR 866.5510. Submissions are reviewed by the Immunology panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CFQ
- Device Class
- Class II
- Regulation Number
- 866.5510
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K981786 | binding site | IGA MININEPH ANTISERUM | November 24, 1999 |
| K990551 | dade behring | IGG FLEX REAGENT CARTRIDGE | March 25, 1999 |
| K990552 | dade behring | IMMUNOGLOBULIN A TEST SYSTEM | March 25, 1999 |
| K990553 | dade behring | IGM FLEX REAGENT CARTRIDGE | March 22, 1999 |
| K951055 | olympus america | OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT | April 17, 1995 |
| K951013 | olympus america | OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT | April 17, 1995 |
| K950900 | olympus america | OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT | March 27, 1995 |
| K891188 | helena laboratories | TITAN GEL IFE TRIVALENT ANTISERUM | March 22, 1989 |
| K890561 | atlantic antibodies | SPQ(TM) ANTIBODY REAGENT SET II FOR IGM | February 23, 1989 |
| K881928 | binding site | MONOCLONAL RADIAL IMMUNODIFFUSION KIT | July 8, 1988 |
| K881827 | binding site | IMMUNOGLOBULIN A TEST SYSTEM | June 10, 1988 |
| K881828 | binding site | IMMUNOGLOBULIN M TEST SYSTEM | June 6, 1988 |