DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC— 510(k) K120977
Substantially EquivalentInternational Technidyne Corp.
FDA 510(k) clearance K120977 for DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC, Substantially Equivalent on 2013-07-03. Applicant: International Technidyne Corp..
Clearance details
- Applicant
- International Technidyne Corp.
- Product code
- Code GGN
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edison, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.