The following data is part of a De Novo classification by Inova Diagnostics, Inc. with the FDA for Quanta Lite Asca (s. Cerevisiae) Igg Elisa.
| DeNovo ID | DEN000007 |
| Device Name: | QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA |
| Classification | Antibodies, Saccharomyces Cerevisiae (s.cerevisiae) |
| Applicant | INOVA DIAGNOSTICS, INC. 10180 Scripps Ranch Blvd. San Diego, CA 92131 |
| Contact | Brys C Myers |
| Product Code | NBT |
| CFR Regulation Number | 866.5785 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K000732 |
| Review Advisory Board | Immunology |
| Classification Advisory | Immunology |
| Type | Post-NSE |
| Date Received | 2000-07-18 |
| Decision Date | 2000-08-16 |
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