The following data is part of a De Novo classification by Ansh Labs Llc with the FDA for Picoamh Elisa.
| DeNovo ID | DEN180004 |
| Device Name: | PicoAMH ELISA |
| Classification | Menopause Test System |
| Applicant | Ansh Labs LLC 445 Medical Center Blvd. Webster, TX 77598 |
| Contact | Ajay Kumar |
| Product Code | QDH |
| CFR Regulation Number | 862.1093 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Toxicology |
| Classification Advisory | Clinical Chemistry |
| Type | Direct |
| Date Received | 2018-01-22 |
| Decision Date | 2018-10-24 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |