Sentosa SA201 HSV 1/2 Qualitative PCR Test— 510(k) K172509
Substantially EquivalentVela 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..
Clearance details
- Applicant
- Vela Diagnostics USA, Inc.
- Product code
- Code OQO
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fairfield, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.