510(k) K033775

HEMOSIL LIQUID ANTITHROMBIN XL by Instrumentation Laboratory CO — Product Code JBQ

K033775 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HEMOSIL LIQUID ANTITHROMBIN XL". The FDA issued a decision of Substantially Equivalent on January 2, 2004. The device falls under product code JBQ (Antithrombin Iii Quantitation), a Class II device regulated under 21 CFR 864.7060. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 2004
Date Received
December 3, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antithrombin Iii Quantitation
Device Class
Class II
Regulation Number
864.7060
Review Panel
HE
Submission Type