ACTICHROME HEPARIN (ANTI-FXA), MODEL 832— 510(k) K013318
Substantially EquivalentAmerican Diagnostica, Inc.
FDA 510(k) clearance K013318 for ACTICHROME HEPARIN (ANTI-FXA), MODEL 832, Substantially Equivalent on 2002-03-08. Applicant: American Diagnostica, Inc.. Device class: 2.
Clearance details
- Applicant
- American Diagnostica, Inc.
- Product code
- Product 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
- Greenwich, CT, US
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