Polymer Technology Systems, Inc. D/B/A Pts Diagnostics

FDA Regulatory Profile

Polymer Technology Systems, Inc. D/B/A Pts Diagnostics appears in FDA public data with 0 recalls, 3 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on February 26, 2022.

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Known Names

polymer technology systems, inc. dba pts diagnostics, polymer technology systems, inc. d/b/a pts diagnostics

Recent 510(k) Clearances

K-NumberDeviceDate
K193406CardioChek Plus Test System; CardioChek Plus Home Test SystemFebruary 26, 2022
K182781PTS Professional Chemistry KitDecember 21, 2018
K162282CardioChek Plus Test System, CardioChek Home Test SystemDecember 22, 2016