510(k) K102552

HEMOSIL LA POSITIVE CONTROL by Instrumentation Laboratory CO — Product Code GGC

K102552 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HEMOSIL LA POSITIVE CONTROL". The FDA issued a decision of Substantially Equivalent on April 5, 2011. The device falls under product code GGC (Control, Plasma, Abnormal), a Class II device regulated under 21 CFR 864.5425. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2011
Date Received
September 7, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Plasma, Abnormal
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type