illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10— 510(k) K151046
Substantially EquivalentMeridian Bioscience, Inc.
FDA 510(k) clearance K151046 for illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10, Substantially Equivalent on 2015-07-17. Applicant: Meridian Bioscience, Inc.. Device class: 2.
Clearance details
- Applicant
- Meridian Bioscience, Inc.
- Product code
- Product code PGI
- Device class
- Class 2
- Regulation
- 21 CFR 866.3309
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cincinnati, OH, US
Recent devices under product code PGI
view all- K233349 — Alinity m HSV 1 & 2 / VZV
- K232286 — Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
- K192376 — Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack
- K180559 — HSV 1 & 2 ELITe MGB Kit; ELITe InGenius
- K173798 — Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
More clearances from Meridian Bioscience, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.