HEMOSIL D-DIMER HS 500 CONTROL— 510(k) K133582
Substantially EquivalentInstrumentation Laboratory
FDA 510(k) clearance K133582 for HEMOSIL D-DIMER HS 500 CONTROL, Substantially Equivalent on 2014-08-15. Applicant: Instrumentation Laboratory. Device class: 2.
Clearance details
- Applicant
- Instrumentation Laboratory
- Product code
- Code GGN
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
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More clearances from Instrumentation Laboratory
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