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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 the device name listed in this FDA 510(k) record. The listed applicant is Elitechgroup. It received FDA 510(k) clearance on 2018-10-29 under 510(k) 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. The listed applicant is Elitechgroup. The 510(k) number is K180559.

When did HSV 1 & 2 ELITe MGB Kit; ELITe InGenius receive FDA 510(k) clearance?

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

Who is the listed applicant for HSV 1 & 2 ELITe MGB Kit; ELITe InGenius?

The FDA 510(k) record lists Elitechgroup as the applicant. This does not by itself establish the device manufacturer.

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 records listing Elitechgroup as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K180627Macroduct Advanced Model 3710K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1K153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II

Related Devices (Code: PGI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233349Alinity m HSV 1 & 2 / VZVAbbott Molecular, Inc.K232286Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna InstrumentQuidel CorporationK192376Simplexa VZV Swab Direct, Simplexa VZV Positive Control PackDiasorin Molecular, LLCK173798Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackDiasorin Molecular, LLCK162451Solana HSV 1+2/VZV AssayQuidel Corporation

Official Source

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

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