HEMOSIL FACTOR II DEFICIENT PLASMA— 510(k) K050661
Substantially EquivalentInstrumentation Laboratory CO
FDA 510(k) clearance K050661 for HEMOSIL FACTOR II DEFICIENT PLASMA, Substantially Equivalent on 2005-05-02. Applicant: Instrumentation Laboratory CO. Device class: 2.
Clearance details
- Applicant
- Instrumentation Laboratory CO
- Product code
- Code GJT
- Device class
- Class 2
- Regulation
- 21 CFR 864.7290
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
Recent devices under product code GJT
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