FDA.report

510(k) K213426

Device
HemosIL ReadiPlasTin
Applicant
Instrumentation Laboratory CO
510(k) number
K213426
Product code
GJS
Decision
Substantially Equivalent (SESE)
Decision date
2022-08-16
Date received
2021-10-21
Regulation
864.7750
Classification name
Test, Time, Prothrombin
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Carol Marble
Address
180 Hartwell Rd. Bedford MA US 01730 01730

FDA Registration Numbers

Source Documents

510(k) summary PDF

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