FDA Product Code
FDA Product Code OWM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.6040
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K101185 | NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY | Iris Molecular Diagnostics | 2011-09-20 | Traditional | PDF ↗ |
Product code OWM · Class II · Immunology. Data: openFDA.