K010558 is an FDA 510(k) clearance for the QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA. This device is classified as a Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control (Class II - Special Controls, product code MLE).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on April 3, 2001, 36 days after receiving the submission on February 26, 2001.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5110.
| 510(k) Number | K010558 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2001 |
| Decision Date | April 03, 2001 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | MLE — Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5110 |