510(k) K182781
K182781 is an FDA 510(k) premarket notification submitted by Polymer Technology Systems, Inc. D/B/A Pts Diagnostics for the device "PTS Professional Chemistry Kit". The FDA issued a decision of Substantially Equivalent (kit) on December 21, 2018. 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
- SESK (Substantially Equivalent (kit))
- Decision Date
- December 21, 2018
- Date Received
- October 1, 2018
- Clearance Type
- Traditional
- 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