FDA Product Code
FDA Product Code NRF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.8625
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K042750 | QC-BEADS | Bioscreen, Inc. | 2004-10-29 | Traditional | PDF ↗ |
| K041600 | QWIKCHECK-BEADS | Medical Electronics Systems , Ltd. | 2004-07-27 | Traditional | PDF ↗ |
| K041240 | SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED | Fertility Solutions, Inc. | 2004-06-02 | Traditional | PDF ↗ |
Product code NRF · Class II · Hematology. Data: openFDA.