510(k) K180559— HSV 1 & 2 ELITe MGB Kit; ELITe InGenius

Substantially Equivalent

Elitechgroup

Clearance details

Applicant: Elitechgroup
Product code: Code PGI
Advisory panel: Microbiology
Date received: 2018-03-01
Decision date: 2018-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bothell, WA, US

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