Sentosa SA201 HSV 1/2 Qualitative PCR Test
K-Number: K172509 · 2018-02-01
ApplicantVela Diagnostics USA, Inc.
Decision Date2018-02-01
Product CodeOQO
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Sentosa SA201 HSV 1/2 Qualitative PCR Test is a medical device manufactured by Vela Diagnostics USA, Inc.. It received FDA 510(k) clearance on 2018-02-01 under approval number K172509. The device is classified under product code OQO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sentosa SA201 HSV 1/2 Qualitative PCR Test?
Sentosa SA201 HSV 1/2 Qualitative PCR Test is a medical device that received FDA 510(k) clearance on 2018-02-01. It is manufactured by Vela Diagnostics USA, Inc.. The 510(k) number is K172509.
When was Sentosa SA201 HSV 1/2 Qualitative PCR Test approved by the FDA?
Sentosa SA201 HSV 1/2 Qualitative PCR Test received FDA 510(k) clearance on 2018-02-01, under approval number K172509.
What company makes Sentosa SA201 HSV 1/2 Qualitative PCR Test?
Sentosa SA201 HSV 1/2 Qualitative PCR Test is manufactured by Vela Diagnostics USA, Inc..
What is the FDA product code for Sentosa SA201 HSV 1/2 Qualitative PCR Test?
The FDA product code for Sentosa SA201 HSV 1/2 Qualitative PCR Test is OQO.
Related Devices (Code: OQO)
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.