510(k) K162282
K162282 is an FDA 510(k) premarket notification submitted by Polymer Technology Systems, Inc. D/B/A Pts Diagnostics for the device "CardioChek Plus Test System, CardioChek Home Test System". The FDA issued a decision of Substantially Equivalent on December 22, 2016. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Polymer Technology Systems, Inc. D/B/A Pts Diagnostics has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2016
- Date Received
- August 15, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Glucose Oxidase, Glucose
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type