TISSUE OF ORIGIN TEST KIT FFPE
FDA 510(k) clearance K120489 · decided 2012-05-17
Clearance details
- K-number
- K120489
- Device name
- TISSUE OF ORIGIN TEST KIT FFPE
- Applicant
- Pathwork Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-02-17
- Decision date
- 2012-05-17
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- OIW
- Device class
- 2
- Regulation number
- 862.3100
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Tissue of Origin Test Kit-FFPE (K173839) | Cancer Genetics, Inc. | 2018-03-15 |
| PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE (K092967) | Pathwork Diagnostics | 2010-06-08 |
| PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST (K080896) | Pathwork Diagnostics, Inc. | 2008-07-30 |
Recalls involving this device
No recalls on record reference this clearance.