Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of SinocareLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Polymer Technology Systems with 30 510(k) clearances and 21 device recalls. The most recent is a device recall dated Sep 18, 2024: A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device….
510(k) clearances: 30
Device recalls: 21
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
02017Records0
220182018Records2vs 2017+2
102019Records10vs 2018+8
620202020Records6vs 2019−4
02021Records0vs 2020−6
220222022Records2vs 2021+2
02023Records0vs 2022−2
120242024Records1vs 2023+1
02025Records0vs 2024−1
020262026 to dateRecords0
Latest Records
Newest first across sources; each opens the record
Polymer Technology Systems, Inc.Polymer Technology SystemsPolymer Technology Systems, Inc. D/B/A Pts DiagnosticsPolymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata.How this page is built
