Submission Details
| 510(k) Number | K001393 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR
Jun 2000
Decision
35d
Days
Class 2
Risk
About This 510(k) Submission
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, 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 review panel. Regulated under 21 CFR 866.5750.
Device Classification
| Product Code | MST — Antibodies, Gliadin |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5750 |
Manufacturer
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