Sentosa SA201 HSV 1/2 Qualitative PCR Test— 510(k) K172509

Name: FDA 510(k) clearance K172509
Creator: U.S. Food and Drug Administration
Published: 2018-02-01

Substantially Equivalent

Vela Diagnostics USA, Inc.

FDA 510(k) clearance K172509 for Sentosa SA201 HSV 1/2 Qualitative PCR Test, Substantially Equivalent on 2018-02-01. Applicant: Vela Diagnostics USA, Inc.. Device class: 2.

Clearance details

Applicant: Vela Diagnostics USA, Inc.
Product code: Code OQO
Device class: Class 2
Regulation: 21 CFR 866.3305
Advisory panel: Microbiology
Date received: 2017-08-21
Decision date: 2018-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfield, NJ, US

Download summary PDF View on FDA.gov ↗

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