ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)— 510(k) K242127
Substantially EquivalentInstrumentation Laboratory (IL) Co.
FDA 510(k) clearance K242127 for ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS), Substantially Equivalent on 2024-08-16. Applicant: Instrumentation Laboratory (IL) Co.. Device class: 2.
Clearance details
- Applicant
- Instrumentation Laboratory (IL) 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
view all- K231031 — ACL TOP Family 70 Series
- K160276 — ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
- 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 (IL) Co.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.