510(k) K080896
- Device
- PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST
- Applicant
- PATHWORK DIAGNOSTICS, INC.
- 510(k) number
- K080896
- Product code
- OIW
- Decision
- Se - With Limitations (SESU)
- Decision date
- 2008-07-30
- Date received
- 2008-03-31
- Regulation
- 862.3100
- Classification name
- Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types
- Medical specialty
- Toxicology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Erika B Ammirati
- Address
- 1196 Borregas Ave., Suite 200 Sunnyvale CA US 94089 94089
Source Documents#
Other 510(k) Records For Product Code OIW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K173839 | Tissue of Origin Test Kit-FFPE | Cancer Genetics, Inc. | 2018-03-15 |
| K120489 | TISSUE OF ORIGIN TEST KIT FFPE | Pathwork Diagnostics, Inc. | 2012-05-17 |
| K092967 | PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE | Pathwork Diagnostics | 2010-06-08 |
Legacy Summary#
summary
FDA Review#
Decision Summary