ACL TOP Family 70 Series— 510(k) K231031
Substantially EquivalentInstrumentation Laboratory Company
FDA 510(k) clearance K231031 for ACL TOP Family 70 Series, Substantially Equivalent on 2023-06-21. Applicant: Instrumentation Laboratory Company. Device class: 2.
Clearance details
- Applicant
- Instrumentation Laboratory Company
- 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
- Traditional
- Location
- Bedford, MA, US
Recent devices under product code GKP
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- K150877 — ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
- K091980 — ACL TOP 700 LAS
- K073377 — ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
More clearances from Instrumentation Laboratory Company
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