FDA.report

510(k) K233790

Device
ACL TOP 970 CL
Applicant
Instrumentation Laboratory
510(k) number
K233790
Product code
JPA
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-29
Date received
2023-11-28
Regulation
864.5425
Classification name
System, Multipurpose For In Vitro Coagulation Studies
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Nikita Malladi
Address
180 Hartwell Rd. Bedford MA US 01730 01730

FDA Registration Numbers

Source Documents

510(k) summary PDF

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