K984135 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR. This device is classified as a Antisera, Fluorescent, Herpesvirus Hominis 1,2 (Class II - Special Controls, product code GQL).
Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on May 26, 1999, 189 days after receiving the submission on November 18, 1998.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305.
| 510(k) Number | K984135 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 1998 |
| Decision Date | May 26, 1999 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | GQL — Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3305 |