HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS— 510(k) K010193
Substantially EquivalentInternational Technidyne Corp.
FDA 510(k) clearance K010193 for HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS, Substantially Equivalent on 2001-06-06. Applicant: International Technidyne Corp.. Device class: 2.
Clearance details
- Applicant
- International Technidyne Corp.
- Product code
- Product code KFF
- Device class
- Class 2
- Regulation
- 21 CFR 864.7525
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edison, NJ, US
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More clearances from International Technidyne Corp.
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