510(k) K143329
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 2015
- Date Received
- November 20, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Trichomonas Vaginalis Nucleic Acid Amplification Test System
- Device Class
- Class II
- Regulation Number
- 866.3860
- Review Panel
- MI
- Submission Type
In vitro nucleic acid amplification test for the qualitative detection of ribosomal rna from trichomonas vaginalis as an aid in the diagnosis of trichomoniasis from vaginal, cervical, urogenital and gynecological specimens from symptomatic patients