FDA Product Code
FDA Product Code CFQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5510
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K981786 | IGA MININEPH ANTISERUM | The Binding Site, Ltd. | 1999-11-24 | Traditional | PDF ↗ |
| K990552 | IMMUNOGLOBULIN A TEST SYSTEM | Dade Behring, Inc. | 1999-03-25 | Traditional | PDF ↗ |
| K990551 | IGG FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 1999-03-25 | Traditional | PDF ↗ |
| K990553 | IGM FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 1999-03-22 | Traditional | PDF ↗ |
| K951013 | OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | 1995-04-17 | Traditional | PDF ↗ |
| K951055 | OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | 1995-04-17 | Traditional | PDF ↗ |
| K950900 | OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | 1995-03-27 | Traditional | PDF ↗ |
| K891188 | TITAN GEL IFE TRIVALENT ANTISERUM | Helena Laboratories | 1989-03-22 | Traditional | PDF ↗ |
| K890561 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGM | Atlantic Antibodies | 1989-02-23 | Traditional | PDF ↗ |
| K881928 | MONOCLONAL RADIAL IMMUNODIFFUSION KIT | The Binding Site, Ltd. | 1988-07-08 | Traditional | PDF ↗ |
| K881827 | IMMUNOGLOBULIN A TEST SYSTEM | The Binding Site, Ltd. | 1988-06-10 | Traditional | PDF ↗ |
| K881828 | IMMUNOGLOBULIN M TEST SYSTEM | The Binding Site, Ltd. | 1988-06-06 | Traditional | PDF ↗ |
Product code CFQ · Class II · Immunology. Data: openFDA.