Medical Device Manufacturer · US , Brea , CA

Beckman-Diagnostic Systems Group - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 1993

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Beckman-Diagnostic Systems Group Chemistry ✕

5 devices

1-5 of 5

Cleared Nov 02, 1994

SYNCHRON CX3 DELTA

Chemistry · 149d

Cleared Jul 06, 1994

BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT

Chemistry · 307d

Cleared Apr 26, 1994

BECKMAN DIRECT BILIRUBIN REAGENT

Chemistry · 249d

Cleared Nov 09, 1993

BECKMAN SYNCHRON LACTATE REAGENT

Chemistry · 70d

Cleared Oct 28, 1993

BECKMAN CHOLESTEROL REAGENT

Chemistry · 70d