510(k) K070017

PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS by Polymer Technology Systems, Inc. — Product Code NBW

K070017 is an FDA 510(k) premarket notification submitted by Polymer Technology Systems, Inc. for the device "PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS". The FDA issued a decision of Substantially Equivalent on January 31, 2007. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Polymer Technology Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2007
Date Received
January 3, 2007
Clearance Type
Special
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