FDA Product Code
FDA Product Code NOZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7470
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K180209 | Diazyme 1,5-AG Assay | Diazyme Laboratories, Inc. | 2018-10-04 | Traditional | PDF ↗ |
| K031604 | GLYCOMARK | Tomen America, Inc. | 2003-09-22 | Traditional | PDF ↗ |
Product code NOZ · Class II · Hematology. Data: openFDA.