ACL TOP— 510(k) K063679
Substantially EquivalentInstrumentation Laboratory CO
FDA 510(k) clearance K063679 for ACL TOP, Substantially Equivalent on 2007-01-12. Applicant: Instrumentation Laboratory CO. Device class: 2.
Clearance details
- Applicant
- Instrumentation Laboratory CO
- Product code
- Code GKP
- Device class
- Class 2
- Regulation
- 21 CFR 864.5400
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bedford, MA, US
Recent devices under product code GKP
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- K091980 — ACL TOP 700 LAS
More clearances from Instrumentation Laboratory CO
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