510(k) K090209

HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS by Instrumentation Laboratory CO — Product Code KFF

K090209 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS". The FDA issued a decision of Substantially Equivalent on June 2, 2009. The device falls under product code KFF (Assay, Heparin), a Class II device regulated under 21 CFR 864.7525. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2009
Date Received
January 28, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Heparin
Device Class
Class II
Regulation Number
864.7525
Review Panel
HE
Submission Type