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FDA 510(k)

HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950

K-Number: K071510 · 2007-09-24

ApplicantFocus Diagnostics, Inc.
Decision Date2007-09-24
Product CodeMXJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950 is the device name listed in this FDA 510(k) record. The listed applicant is Focus Diagnostics, Inc.. It received FDA 510(k) clearance on 2007-09-24 under 510(k) number K071510. The device is classified under product code MXJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950?

HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950 is a medical device that received FDA 510(k) clearance on 2007-09-24. The listed applicant is Focus Diagnostics, Inc.. The 510(k) number is K071510.

When did HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950 receive FDA 510(k) clearance?

HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950 received FDA 510(k) clearance on 2007-09-24, under 510(k) number K071510.

Who is the listed applicant for HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950?

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

What is the FDA product code for HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950?

The FDA product code for HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950 is MXJ.

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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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