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

35

Total

35

Cleared

0

Denied

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

8 devices

1-8 of 8

Cleared Jul 28, 1994

OPUS FT4 TEST SYSTEM

Chemistry · 176d

Cleared Sep 08, 1993

Chemistry · 78d

Cleared Sep 08, 1993

Chemistry · 42d

Cleared Jul 08, 1993

OPUS(R) TOTAL B-HCG TEST SYSTEM

Chemistry · 57d

Cleared Jun 07, 1993

OPUS MAGNUM ANALYZER

Chemistry · 182d

Cleared Sep 11, 1991

OPUS(R) PLUS ANALYZER

Chemistry · 49d

Cleared Jul 30, 1990

OPUS TM T-UPTAKE TEST SYSTEM

Chemistry · 34d

Cleared Jul 05, 1990

OPUS TSH TEST SYSTEM

Chemistry · 42d