Panels › Immunology › Product code CFQ · Class 2
Radioimmunoassay, Immunoglobulins (G, A, M)
Regulation 866.5510
0510(k)s in 12 months (12 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in CFQ
| Company | 510(k)s | Recalls |
|---|---|---|
| The Binding Site, Ltd. | 4 | 0 |
| Dade Behring, Inc. | 3 | 0 |
| Olympus America, Inc. | 3 | 0 |
| Atlantic Antibodies | 1 | 0 |
| Helena Laboratories | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 24, 1999 | K981786 | IGA MININEPH ANTISERUM The Binding Site, Ltd. | CFQ |
| Mar 25, 1999 | K990552 | IMMUNOGLOBULIN A TEST SYSTEM Dade Behring, Inc. | CFQ |
| Mar 25, 1999 | K990551 | IGG FLEX REAGENT CARTRIDGE Dade Behring, Inc. | CFQ |
| Mar 22, 1999 | K990553 | IGM FLEX REAGENT CARTRIDGE Dade Behring, Inc. | CFQ |
| Apr 17, 1995 | K951055 | OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT Olympus America, Inc. | CFQ |
| Apr 17, 1995 | K951013 | OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT Olympus America, Inc. | CFQ |
| Mar 27, 1995 | K950900 | OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT Olympus America, Inc. | CFQ |
| Mar 22, 1989 | K891188 | TITAN GEL IFE TRIVALENT ANTISERUM Helena Laboratories | CFQ |
| Feb 23, 1989 | K890561 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGM Atlantic Antibodies | CFQ |
| Jul 8, 1988 | K881928 | MONOCLONAL RADIAL IMMUNODIFFUSION KIT The Binding Site, Ltd. | CFQ |
| Jun 10, 1988 | K881827 | IMMUNOGLOBULIN A TEST SYSTEM The Binding Site, Ltd. | CFQ |
| Jun 6, 1988 | K881828 | IMMUNOGLOBULIN M TEST SYSTEM The Binding Site, Ltd. | CFQ |
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