FDA Product Code
FDA Product Code JBY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.6675
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K912201 | PACKS-4 (TM) ANALYZER | Helena Laboratories | 1991-08-16 | Traditional | PDF ↗ |
| K771198 | LUMI-AGGREGOMETER | Chrono-Log Corp. | 1977-08-02 | Traditional | PDF ↗ |
Product code JBY · Class II · Hematology. Data: openFDA.