K000733 is an FDA 510(k) clearance for the QUANTA LITE ASCA (S. CEREVISIAE) IGA 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 Cleared decision on May 21, 2001, 441 days after receiving the submission on March 6, 2000.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5785.
| 510(k) Number | K000733 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2000 |
| Decision Date | May 21, 2001 |
| Days to Decision | 441 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | NBT — Antibodies, Saccharomyces Cerevisiae (s.cerevisiae) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5785 |