Atlas FDA

HemosIL Liquid Anti-Xa

FDA 510(k) clearance K213464 · decided 2022-10-04

Clearance details

K-number
K213464
Device name
HemosIL Liquid Anti-Xa
Applicant
Instrumentation Laboratory CO
Decision
Substantially Equivalent
Date received
2021-10-28
Decision date
2022-10-04
Days to decision
341 days
Clearance type
Special
Product code
KFF
Device class
2
Regulation number
864.7525
Medical specialty
Hematology
Advisory committee
Hematology
Location
Bedford, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
HemosIL LMW Heparin Controls; Part Number: 0020300200; recall (Z-2323-2025)Instrumentation Laboratory2025-08-13
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic recall (Z-1020-2025)Instrumentation Laboratory2025-01-24