Medical Device Manufacturer · US , Mchenry , IL

Serono Laboratories, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1978

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Serono Laboratories, Inc. Chemistry ✕

8 devices

1-8 of 8

Cleared Mar 02, 1984

ALDOSTERONE RADIOIMMUNOASSAY TEST KIT

Chemistry · 78d

Cleared Mar 31, 1981

ESTRIOL RADIOIMMUNOASSAY TEST KIT

Chemistry · 15d

Cleared Mar 27, 1981

HUMAN PLACENTAL LACTOGEN RADIOIMMUNO-

Chemistry · 18d

Cleared Oct 30, 1979

PAP-CHECK RIA KIT

Chemistry · 18d

Cleared May 23, 1979

ESTRADIOL RIA KIT

Chemistry · 44d

Cleared May 03, 1979

Chemistry · 57d

Cleared Feb 22, 1979

RIA KIT, GLUCOSE

Chemistry · 57d

Cleared Jan 17, 1979

RIA KIT, NEONATAL T4

Chemistry · 33d