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FDA 510(k)

HSV 1 & 2 ELITe MGB Kit; ELITe InGenius

K-Number: K180559 · 2018-10-29

ApplicantElitechgroup
Decision Date2018-10-29
Product CodePGI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HSV 1 & 2 ELITe MGB Kit; ELITe InGenius is a medical device manufactured by Elitechgroup. It received FDA 510(k) clearance on 2018-10-29 under approval number K180559. The device is classified under product code PGI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HSV 1 & 2 ELITe MGB Kit; ELITe InGenius?

HSV 1 & 2 ELITe MGB Kit; ELITe InGenius is a medical device that received FDA 510(k) clearance on 2018-10-29. It is manufactured by Elitechgroup. The 510(k) number is K180559.

When was HSV 1 & 2 ELITe MGB Kit; ELITe InGenius approved by the FDA?

HSV 1 & 2 ELITe MGB Kit; ELITe InGenius received FDA 510(k) clearance on 2018-10-29, under approval number K180559.

What company makes HSV 1 & 2 ELITe MGB Kit; ELITe InGenius?

HSV 1 & 2 ELITe MGB Kit; ELITe InGenius is manufactured by Elitechgroup.

What is the FDA product code for HSV 1 & 2 ELITe MGB Kit; ELITe InGenius?

The FDA product code for HSV 1 & 2 ELITe MGB Kit; ELITe InGenius is PGI.

Other Devices by Elitechgroup

K153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1

Related Devices (Code: PGI)

K162451Solana HSV 1+2/VZV AssayQuidel Corporation K173798Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackDiasorin Molecular, LLC K192376Simplexa VZV Swab Direct, Simplexa VZV Positive Control PackDiasorin Molecular, LLC K232286Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna InstrumentQuidel Corporation K233349Alinity m HSV 1 & 2 / VZVAbbott Molecular, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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