HITT BY HEMOCHRON(R)— 510(k) K910181
Substantially EquivalentInternational Technidyne Corp.
FDA 510(k) clearance K910181 for HITT BY HEMOCHRON(R), Substantially Equivalent on 1991-05-10. 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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