Medical Device Manufacturer · US , Westwood , MA

Pb Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices

35 submissions · 35 cleared · Since 1988

Recent clearances: OPUS FT4 TEST SYSTEM, OPUS PROCAINAMIDE TEST SYSTEM, OPUS CMV-G

View 35 510(k) Devices ↓

35

Total

35

Cleared

0

Denied

FDA 510(k) Regulatory Record - Pb Diagnostic Systems, Inc. Immunology ✕

3 devices

1-3 of 3

Cleared Mar 18, 1992

OPUS FERRITIN TEST SYSTEM

Immunology · 85d

Cleared Mar 17, 1992

OPUS MYOGLOBIN TEST SYSTEM

Immunology · 82d

Cleared Aug 12, 1991

Immunology · 109d