HemosIL Chromogenic Factor IX— 510(k) K230852
Substantially EquivalentInstrumentation Laboratory Company
FDA 510(k) clearance K230852 for HemosIL Chromogenic Factor IX, Substantially Equivalent on 2023-12-13. Applicant: Instrumentation Laboratory Company. Device class: 2.
Clearance details
- Applicant
- Instrumentation Laboratory Company
- Product code
- Code GGP
- 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 GGP
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