Atlas FDA

IL TEST HEPARIN

FDA 510(k) clearance K980242 · decided 1998-03-19

Clearance details

K-number
K980242
Device name
IL TEST HEPARIN
Applicant
Instrumentation Laboratory CO
Decision
Substantially Equivalent
Date received
1998-01-23
Decision date
1998-03-19
Days to decision
55 days
Clearance type
Traditional
Product code
KFF
Device class
2
Regulation number
864.7525
Medical specialty
Hematology
Advisory committee
Hematology
Location
Lexington, MA, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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ACTICHROME HEPARIN (ANTI-FIIA) (K013637)American Diagnostica, Inc.2002-04-16
ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 (K013318)American Diagnostica, Inc.2002-03-08
ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN (K010455)Diagnostica-Stago2001-06-07
HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS (K010193)International Technidyne Corp.2001-06-06
COAMATIC HEPARIN (K983178)Instrumentation Laboratory CO1998-11-03
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Recalls involving this device

RecordFirmDate
HemosIL LMW Heparin Controls; Part Number: 0020300200; recall (Z-2323-2025)Instrumentation Laboratory2025-08-13