HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls— 510(k) K170854
Substantially EquivalentInstrumentation Laboratory CO
FDA 510(k) clearance K170854 for HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls, Substantially Equivalent on 2017-09-08. Applicant: Instrumentation Laboratory CO. Device class: 2.
Clearance details
- Applicant
- Instrumentation Laboratory CO
- Product code
- Code LCO
- Device class
- Class 2
- Regulation
- 21 CFR 864.7695
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
Recent devices under product code LCO
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