HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II— 510(k) K882481
Substantially EquivalentInternational Technidyne Corp.
FDA 510(k) clearance K882481 for HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II, Substantially Equivalent on 1988-08-30. 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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