HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS— 510(k) K092181
Substantially EquivalentInstrumentation Laboratory CO
FDA 510(k) clearance K092181 for HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS, Substantially Equivalent on 2010-03-11. Applicant: Instrumentation Laboratory CO. Device class: 2.
Clearance details
- Applicant
- Instrumentation Laboratory CO
- Product code
- Code MID
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
Recent devices under product code MID
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