K081345
Substantially Equivalent for Some IndicationsAXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)
- Applicant
- Thermogenesis Corp.
- Product code
- JQC
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Abbreviated
- Location
- Rancho Cordova, CA, US
Adverse events under product code JQC
product code JQC- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.