HEMOSIL D-DIMER— 510(k) K073042
Substantially EquivalentInstrumentation Laboratory
FDA 510(k) clearance K073042 for HEMOSIL D-DIMER, Substantially Equivalent on 2008-07-31. Applicant: Instrumentation Laboratory. Device class: 2.
Clearance details
- Applicant
- Instrumentation Laboratory
- Product code
- Code DAP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7320
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lexington, MA, US
Recent devices under product code DAP
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