CFQ
12 FDA 510(k) clearances · Product code
38 daysmedian time to decision
60 days90th percentile
12clearances measured
FDA profile
- Official device name
- Radioimmunoassay, Immunoglobulins (G, A, M)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| IGA MININEPH ANTISERUM (K981786) | The Binding Site, Ltd. | 1999-11-24 |
| IMMUNOGLOBULIN A TEST SYSTEM (K990552) | Dade Behring, Inc. | 1999-03-25 |
| IGG FLEX REAGENT CARTRIDGE (K990551) | Dade Behring, Inc. | 1999-03-25 |
| IGM FLEX REAGENT CARTRIDGE (K990553) | Dade Behring, Inc. | 1999-03-22 |
| OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT (K951055) | Olympus America, Inc. | 1995-04-17 |
| OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT (K951013) | Olympus America, Inc. | 1995-04-17 |
| OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT (K950900) | Olympus America, Inc. | 1995-03-27 |
| TITAN GEL IFE TRIVALENT ANTISERUM (K891188) | Helena Laboratories | 1989-03-22 |
| SPQ(TM) ANTIBODY REAGENT SET II FOR IGM (K890561) | Atlantic Antibodies | 1989-02-23 |
| MONOCLONAL RADIAL IMMUNODIFFUSION KIT (K881928) | The Binding Site, Ltd. | 1988-07-08 |
| IMMUNOGLOBULIN A TEST SYSTEM (K881827) | The Binding Site, Ltd. | 1988-06-10 |
| IMMUNOGLOBULIN M TEST SYSTEM (K881828) | The Binding Site, Ltd. | 1988-06-06 |
Track CFQ automatically
Every clearance here is in the API, with alerts when new ones post.