PTS Professional Chemistry Kit
K-Number: K182781 · 2018-12-21
Decision Date2018-12-21
Product CodeCGA
Advisory CommitteeCH
DecisionUnknown
Device Summary
PTS Professional Chemistry Kit is a medical device manufactured by Polymer Technology Systems, Inc. D/B/A Pts Diagnostics. It received FDA 510(k) clearance on 2018-12-21 under approval number K182781. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Unknown.
Frequently Asked Questions
What is the PTS Professional Chemistry Kit?
PTS Professional Chemistry Kit is a medical device that received FDA 510(k) clearance on 2018-12-21. It is manufactured by Polymer Technology Systems, Inc. D/B/A Pts Diagnostics. The 510(k) number is K182781.
When was PTS Professional Chemistry Kit approved by the FDA?
PTS Professional Chemistry Kit received FDA 510(k) clearance on 2018-12-21, under approval number K182781.
What company makes PTS Professional Chemistry Kit?
PTS Professional Chemistry Kit is manufactured by Polymer Technology Systems, Inc. D/B/A Pts Diagnostics.
What is the FDA product code for PTS Professional Chemistry Kit?
The FDA product code for PTS Professional Chemistry Kit is CGA.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.