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PTS Professional Chemistry Kit

by Polymer Technology Systems, Inc. D/B/A Pts Diagnostics 510(k)

Active United States

510(k) K182781

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESK Substantially Equivalent — Kit · Traditional NumberK182781 Date21 Dec 2018ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1373-2019 FDA Class II initiated 16 Jan 2019

    Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed

Specification

510(k)

510(k) Number
FDA Product Code
CGA
Device Class
Class II
Regulation
21 CFR Part 862.1345
Advisory Committee
Clinical Chemistry
FDA Decision
SESK Substantially Equivalent — Kit

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