FDA Product Code
FDA Product Code KQI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7455
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K880653 | HBF DILUENT | Helena Laboratories | 1988-04-21 | Traditional | PDF ↗ |
| K812226 | HELENA HBF QUIPLATE CONTROL | Helena Laboratories | 1981-09-01 | Traditional | PDF ↗ |
| K810475 | HELENA HEMOGLOBIN F CONTROLS | Helena Laboratories | 1981-03-26 | Traditional | PDF ↗ |
| K791143 | SICKLE-CELL F TEST | Isolab, Inc. | 1979-07-17 | Traditional | PDF ↗ |
Product code KQI · Class II · Hematology. Data: openFDA.