AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)— 510(k) K081345
Substantially Equivalent for Some IndicationsThermogenesis Corp.
FDA 510(k) clearance K081345 for AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY), Substantially Equivalent for Some Indications on 2008-07-10. Applicant: Thermogenesis Corp.. Device class: 1.
Clearance details
- Applicant
- Thermogenesis Corp.
- Product code
- Code JQC
- Device class
- Class 1
- Regulation
- 21 CFR 862.2050
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Abbreviated
- Location
- Rancho Cordova, CA, US
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More clearances from Thermogenesis Corp.
view allAdverse 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.