FDA 510(k)

Sentosa SA201 HSV 1/2 Qualitative PCR Test

K-Number: K172509 · 2018-02-01

Decision Date2018-02-01

Product CodeOQO

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Sentosa SA201 HSV 1/2 Qualitative PCR Test is the device name listed in this FDA 510(k) record. The listed applicant is Vela Diagnostics USA, Inc.. It received FDA 510(k) clearance on 2018-02-01 under 510(k) 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. The listed applicant is Vela Diagnostics USA, Inc.. The 510(k) number is K172509.

When did Sentosa SA201 HSV 1/2 Qualitative PCR Test receive FDA 510(k) clearance?

Sentosa SA201 HSV 1/2 Qualitative PCR Test received FDA 510(k) clearance on 2018-02-01, under 510(k) number K172509.

Who is the listed applicant for Sentosa SA201 HSV 1/2 Qualitative PCR Test?

The FDA 510(k) record lists Vela Diagnostics USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162673Aptima Herpes Simplex Viruses 1 & 2 AssayHologic, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.