The following data is part of a premarket notification filed by Elitechgroup with the FDA for Hsv 1 & 2 Elite Mgb Kit; Elite Ingenius.
| Device ID | K180559 |
| 510k Number | K180559 |
| Device Name: | HSV 1 & 2 ELITe MGB Kit; ELITe InGenius |
| Classification | Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples |
| Applicant | ELITechGroup 21720 23rd Drive SE Suite 150 Bothell, WA 98021 |
| Contact | Terry Trimingham |
| Correspondent | Walt Mahoney ELITechGroup 21720 23rd Drive SE Suite 150 Bothell, WA 98021 |
| Product Code | PGI |
| CFR Regulation Number | 866.3309 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-01 |
| Decision Date | 2018-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03661540900006 | K180559 | 000 |
| 03661540950025 | K180559 | 000 |