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

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
6
Compliance Actions
1

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