510(k) K242127
K242127 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory (IL) Co. for the device "ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)". The FDA issued a decision of Substantially Equivalent on August 16, 2024. The device falls under product code GKP (Instrument, Coagulation, Automated), a Class II device regulated under 21 CFR 864.5400. Instrumentation Laboratory (IL) Co. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 2024
- Date Received
- July 19, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Coagulation, Automated
- Device Class
- Class II
- Regulation Number
- 864.5400
- Review Panel
- HE
- Submission Type