HEPARIN MANAGEMENT TEST CARD; HMT CARD— 510(k) K943283
Substantially EquivalentCardiovascular Diagnostics, Inc.
FDA 510(k) clearance K943283 for HEPARIN MANAGEMENT TEST CARD; HMT CARD, Substantially Equivalent on 1995-05-10. Applicant: Cardiovascular Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiovascular Diagnostics, Inc.
- Product code
- 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
- Raleigh, NC, US
Recent devices under product code KFF
view all- K213464 — HemosIL Liquid Anti-Xa
- K162540 — INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls
- K111822 — STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
- K090209 — HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
- K050367 — BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6
More clearances from Cardiovascular Diagnostics, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.