CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL— 510(k) K103314
Substantially EquivalentMedtronic, Inc.
FDA 510(k) clearance K103314 for CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL, Substantially Equivalent on 2010-12-03. Applicant: Medtronic, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic, Inc.
- Product code
- Code GGN
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mounds View, MN, US
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More clearances from Medtronic, Inc.
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