Medical Device Manufacturer · US , Westwood , MA

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

4 submissions · 4 cleared · Since 1991

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Pb Diagnostics, Inc. Microbiology ✕

3 devices

1-3 of 3

Cleared Apr 08, 1993

OPUS SEROLOGY CONTROLS

Microbiology · 147d

Cleared Sep 14, 1992

OPUS(R) TOXO-G TEST SYSTEM

Microbiology · 167d

Cleared Oct 28, 1991

OPUS(R) ANTI CMV-M

Microbiology · 109d