Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.

FDA Regulatory Profile

Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. appears in FDA public data with 2 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0223-2025, Class II) was initiated on September 18, 2024.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Known Names

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

Recent Recalls

NumberClassProductDate
Z-0223-2025Class IIA1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitoSeptember 18, 2024
Z-1741-2022Class IIIPTS Panels CHOL+GLU Test Strips (REF 1765)August 16, 2022