FDA Product Code
FDA Product Code NGA — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1300
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K070484 | QUANTRX FEMALE FERTILITY TEST | Quantrx Biomedical Corporation | 2007-10-22 | Traditional | PDF ↗ |
| K032002 | FERTELL FEMALE FERTILITY TEST | Genosis, Inc. | 2003-10-30 | Traditional | PDF ↗ |
Product code NGA · Class I · Clinical Chemistry. Data: openFDA.