510(k) K193406
K193406 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 Plus Home Test System". The FDA issued a decision of Substantially Equivalent on February 26, 2022. 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. D/B/A Pts Diagnostics has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 2022
- Date Received
- December 9, 2019
- 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