SeraQuest HSV Type 2 Specific IgG
K-Number: K181514 · 2019-06-13
ApplicantQuest International, Inc.
Decision Date2019-06-13
Product CodeMYF
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
SeraQuest HSV Type 2 Specific IgG is a medical device manufactured by Quest International, Inc.. It received FDA 510(k) clearance on 2019-06-13 under approval number K181514. The device is classified under product code MYF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SeraQuest HSV Type 2 Specific IgG?
SeraQuest HSV Type 2 Specific IgG is a medical device that received FDA 510(k) clearance on 2019-06-13. It is manufactured by Quest International, Inc.. The 510(k) number is K181514.
When was SeraQuest HSV Type 2 Specific IgG approved by the FDA?
SeraQuest HSV Type 2 Specific IgG received FDA 510(k) clearance on 2019-06-13, under approval number K181514.
What company makes SeraQuest HSV Type 2 Specific IgG?
SeraQuest HSV Type 2 Specific IgG is manufactured by Quest International, Inc..
What is the FDA product code for SeraQuest HSV Type 2 Specific IgG?
The FDA product code for SeraQuest HSV Type 2 Specific IgG is MYF.
Other Devices by Quest International, Inc.
Related Devices (Code: MYF)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.