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FDA 510(k)

PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST

K-Number: K080896 · 2008-07-30

ApplicantPathwork Diagnostics, Inc.
Decision Date2008-07-30
Product CodeOIW
Advisory CommitteeTX
DecisionUnknown

Device Summary

PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Pathwork Diagnostics, Inc.. It received FDA 510(k) clearance on 2008-07-30 under 510(k) number K080896. The device is classified under product code OIW. It was reviewed by the TX advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST?

PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST is a medical device that received FDA 510(k) clearance on 2008-07-30. The listed applicant is Pathwork Diagnostics, Inc.. The 510(k) number is K080896.

When did PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST receive FDA 510(k) clearance?

PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST received FDA 510(k) clearance on 2008-07-30, under 510(k) number K080896.

Who is the listed applicant for PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST?

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

What is the FDA product code for PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST?

The FDA product code for PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST is OIW.

Related Clinical Trials

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Other records listing Pathwork Diagnostics, Inc. 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.

K120489TISSUE OF ORIGIN TEST KIT FFPE

Related Devices (Code: OIW)

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.

K173839Tissue of Origin Test Kit-FFPECancer Genetics, Inc.K120489TISSUE OF ORIGIN TEST KIT FFPEPathwork Diagnostics, Inc.K092967PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPEPathwork Diagnostics

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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