510(k) K223187
- Device
- HemosIL Liquid Anti-Xa
- Applicant
- Instrumentation Laboratory CO
- 510(k) number
- K223187
- Product code
- QLU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-06-23
- Date received
- 2022-10-12
- Regulation
- 864.7295
- Classification name
- Anti-Factor Xa Activity Test System, Apixaban
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Carol Marble
- Address
- 180 Hartwell Rd. Bedford MA US 01730 01730
FDA Registration Numbers#
- 2431530
- 9610806
- 3037000637