The following data is part of a De Novo classification by Kronus Market Development Associates, Inc. with the FDA for Zinc Transporter 8 Antibody (znt8ab) Elisa Assay Kit.
| DeNovo ID | DEN140001 |
| Device Name: | ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT |
| Classification | Zinc Transporter 8 Auto-antibody |
| Applicant | KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. 170 S. Seneca Springs Way suite 105 Star, ID 83669 |
| Contact | Tanis Jimenez |
| Product Code | PHF |
| CFR Regulation Number | 866.5670 [🔎] |
| 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 | Immunology |
| Classification Advisory | Immunology |
| Type | Post-NSE |
| Date Received | 2014-06-16 |
| Decision Date | 2014-08-20 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B126KR77300 | DEN140001 | 000 |