HEMOCHRON(R) APTT, MODIFICATION— 510(k) K911994
Substantially EquivalentInternational Technidyne Corp.
FDA 510(k) clearance K911994 for HEMOCHRON(R) APTT, MODIFICATION, Substantially Equivalent on 1991-07-17. Applicant: International Technidyne Corp.. Device class: 2.
Clearance details
- Applicant
- International Technidyne Corp.
- Product code
- Code GFO
- Device class
- Class 2
- Regulation
- 21 CFR 864.7925
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edison, NJ, US
Recent devices under product code GFO
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