HSV 1 & 2 ELITe MGB Kit; ELITe InGenius— 510(k) K180559
Substantially EquivalentElitechgroup
FDA 510(k) clearance K180559 for HSV 1 & 2 ELITe MGB Kit; ELITe InGenius, Substantially Equivalent on 2018-10-29. Applicant: Elitechgroup. Device class: 2.
Clearance details
- Applicant
- Elitechgroup
- Product code
- 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
- Bothell, WA, 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
- K173798 — Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
- K162451 — Solana HSV 1+2/VZV Assay
More clearances from Elitechgroup
view all- K171401 — ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1
- K153644 — ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II
- K151113 — ELITech Clinical Systems CALCIUM ARSENAZO
- K151552 — ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II
- K141265 — ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.