FDA Product Code
FDA Product Code PFX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5920
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K163367 | GenetiSure Dx Postnatal Assay | Agilent Technologies, Inc. | 2017-08-11 | Traditional | PDF ↗ |
| DEN130018 | CYTOSCAN(R) DX | Affymetrix, Inc. | 2014-01-17 | Post-NSE | — |
Product code PFX · Class II · Immunology. Data: openFDA.