K242127
- 510(k) number
- K242127
- Device name
- ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)
- Applicant
- Instrumentation Laboratory (IL) Co. MA · US
- Product code
- GKP — Instrument, Coagulation, Automated
- Decision date
- 2024-08-16
- Date received
- 2024-07-19
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Hematology
510(k) Summary (official FDA PDF): K242127.pdf
Official FDA record: K242127
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.