K983801 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO. This device is classified as a Epstein-barr Virus, Other (Class I - General Controls, product code LSE).
Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on December 10, 1998, 43 days after receiving the submission on October 28, 1998.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3235.
| 510(k) Number | K983801 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 1998 |
| Decision Date | December 10, 1998 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LSE — Epstein-barr Virus, Other |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3235 |