5 devices · 4 companies · 2005 to 2018
AI-enabled clinical toxcicology devices on FDA's list
5 devices in the Clinical Toxcicology panel, 2005 to 2018, from 4 companies across 2 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 5 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes in the Clinical Toxcicology panel
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Product code | FDA |
|---|---|---|---|---|
| Tissue of Origin Test Kit-FFPEK173839 · 510(k) | Cancer Genetics, Inc. | OIW | database entry | |
| TISSUE OF ORIGIN TEST KIT FFPEK120489 · 510(k) | PATHWORK DIAGNOSTICS, INC. | OIW | database entry | |
| PATHWORK TISSUE OF ORIGIN TEST KIT-FFPEK092967 · 510(k) | PATHWORK DIAGNOSTICS | OIW | database entry | |
| PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TESTK080896 · 510(k) | PATHWORK DIAGNOSTICS, INC. | OIW | database entry | |
| BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUK043341 · 510(k) | BIO-RAD LABORATORIES, INC. | NVI | database entry |
Every panel in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.