Pathwork Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Pathwork Diagnostics, Inc. makes
Pathwork Diagnostics, Inc. develops diagnostic tests for determining the tissue of origin in metastatic cancer cases, including the Tissue of Origin Test and the Tissue of Origin Test Kit for FFPE (formalin-fixed, paraffin-embedded) samples. These tests assist pathologists in identifying the primary site of cancer when direct evidence is unavailable.
The company’s diagnostic tests are classified as Class II medical devices under FDA regulations and are authorised via the 510(k) pathway. These products are listed in the FDA’s 510(k) database, reflecting their regulatory status in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Pathwork Diagnostics Tissue Of Origin Test Ref K080896
Regimes: 510(k) Registry: 510(k)Tissue Of Origin Test Kit Ffpe Ref K120489
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pathwork Diagnostics, Inc. have in the registry?
The registry currently lists 3 devices for Pathwork Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pathwork Diagnostics, Inc.'s devices?
Among its 3 most recently registered devices, Pathwork Diagnostics, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Pathwork Diagnostics, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Pathwork Diagnostics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pathwork Diagnostics, Inc. in the registry?
The most recently registered devices listed for Pathwork Diagnostics, Inc. include PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE, PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST and TISSUE OF ORIGIN TEST KIT FFPE.