K091753 is an FDA 510(k) clearance for the ELVIS HSV ID AND D3 TYPING TEST SYSTEM. This device is classified as a Antisera, Fluorescent, Herpesvirus Hominis 1,2 (Class II - Special Controls, product code GQL).
Submitted by Diagnostic Hybrids, Inc. (Athens, US). The FDA issued a Cleared decision on August 28, 2009, 73 days after receiving the submission on June 16, 2009.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305.
| 510(k) Number | K091753 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2009 |
| Decision Date | August 28, 2009 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GQL — Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3305 |