510(k) K150877
K150877 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS". The FDA issued a decision of Substantially Equivalent on December 13, 2015. The device falls under product code GKP (Instrument, Coagulation, Automated), a Class II device regulated under 21 CFR 864.5400. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 2015
- Date Received
- April 1, 2015
- Clearance Type
- Traditional
- 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