ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II— 510(k) K944691
Substantially EquivalentInternational Technidyne Corp.
FDA 510(k) clearance K944691 for ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II, Substantially Equivalent on 1995-03-15. Applicant: International Technidyne Corp.. Device class: 2.
Clearance details
- Applicant
- International Technidyne Corp.
- 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
- Traditional
- Location
- Edison, NJ, US
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