Device Classification Name |
Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
|
510(k) Number |
K180559 |
Device Name |
HSV 1 & 2 ELITe MGB Kit; ELITe InGenius |
Applicant |
ELITechGroup |
21720 23rd Drive SE Suite 150 |
Bothell,
WA
98021
|
|
Applicant Contact |
Terry Trimingham |
Correspondent |
ELITechGroup |
21720 23rd Drive SE Suite 150 |
Bothell,
WA
98021
|
|
Correspondent Contact |
Walt Mahoney |
Regulation Number | 866.3309
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/01/2018 |
Decision Date | 10/29/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|