K993250 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM.. 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 November 12, 1999, 45 days after receiving the submission on September 28, 1999.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5750.
| 510(k) Number | K993250 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 1999 |
| Decision Date | November 12, 1999 |
| Days to Decision | 45 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 |