510(k) K052762

LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 by Agamatrix, Inc. — Product Code NBW

K052762 is an FDA 510(k) premarket notification submitted by Agamatrix, Inc. for the device "LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067". The FDA issued a decision of Substantially Equivalent on January 23, 2006. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Agamatrix, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2006
Date Received
September 30, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Blood Glucose, Over The Counter
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type