510(k) K120489
- Device
- TISSUE OF ORIGIN TEST KIT FFPE
- Applicant
- PATHWORK DIAGNOSTICS, INC.
- 510(k) number
- K120489
- Product code
- OIW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-05-17
- Date received
- 2012-02-17
- 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
- ANNA LONGWELL
- Address
- 1900 Embarcadero Rd. Palo Alto CA US 94303 94303
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 |
| K092967 | PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE | Pathwork Diagnostics | 2010-06-08 |
| K080896 | PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST | Pathwork Diagnostics, Inc. | 2008-07-30 |
Legacy Summary#
summary
FDA Review#
Decision Summary