K984126 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR. This device is classified as a Antigen, Ebv, Capsid (Class I - General Controls, product code MCD).
Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on January 11, 1999, 54 days after receiving the submission on November 18, 1998.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3235.
| 510(k) Number | K984126 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 1998 |
| Decision Date | January 11, 1999 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | MCD — Antigen, Ebv, Capsid |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3235 |