RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST— 510(k) K993519
Substantially EquivalentCardiovascular Diagnostics, Inc.
FDA 510(k) clearance K993519 for RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST, Substantially Equivalent on 2000-01-14. Applicant: Cardiovascular Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiovascular Diagnostics, Inc.
- Product code
- Code JOX
- Device class
- Class 2
- Regulation
- 21 CFR 864.5680
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raleigh, NC, US
Recent devices under product code JOX
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