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FDA 510(k)

STRATIFY JCV DXSELECT

K-Number: K120986 · 2012-08-16

ApplicantFocus Diagnostics, Inc.
Decision Date2012-08-16
Product CodeOYP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STRATIFY JCV DXSELECT 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 2012-08-16 under 510(k) number K120986. The device is classified under product code OYP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATIFY JCV DXSELECT?

STRATIFY JCV DXSELECT is a medical device that received FDA 510(k) clearance on 2012-08-16. The listed applicant is Focus Diagnostics, Inc.. The 510(k) number is K120986.

When did STRATIFY JCV DXSELECT receive FDA 510(k) clearance?

STRATIFY JCV DXSELECT received FDA 510(k) clearance on 2012-08-16, under 510(k) number K120986.

Who is the listed applicant for STRATIFY JCV DXSELECT?

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 STRATIFY JCV DXSELECT?

The FDA product code for STRATIFY JCV DXSELECT is OYP.

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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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