K001393 is an FDA 510(k) clearance for the THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR. This device is classified as a Antibodies, Gliadin (Class II - Special Controls, product code MST).
Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on June 7, 2000, 35 days after receiving the submission on May 3, 2000.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5750.
| 510(k) Number | K001393 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2000 |
| Decision Date | June 07, 2000 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | MST — Antibodies, Gliadin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5750 |