DEN000007 is an FDA 510(k) submission for the QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA. This device is classified as a Antibodies, Saccharomyces Cerevisiae (s.cerevisiae) (Class II - Special Controls, product code NBT).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Not Cleared (DENG) decision on August 16, 2000.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5785.
| 510(k) Number | DEN000007 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | July 18, 2000 |
| Decision Date | August 16, 2000 |
| Days to Decision | 29 days |
| Submission Type | Post-NSE |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | NBT — Antibodies, Saccharomyces Cerevisiae (s.cerevisiae) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5785 |