ENOXAPARIN TEST CARD— 510(k) K013305
Substantially EquivalentCardiovascular Diagnostics, Inc.
FDA 510(k) clearance K013305 for ENOXAPARIN TEST CARD, Substantially Equivalent on 2002-08-23. 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
- Morrisville, NC, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.