510(k) K070017
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