Medical Device Manufacturer · US , Abbott Park , IL

Abbott Mfg., Inc. - FDA 510(k) Cleared Devices

14 submissions · 13 cleared · Since 1990

14

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - Abbott Mfg., Inc. Chemistry ✕

8 devices

1-8 of 8

Cleared May 27, 1998

Chemistry · 34d

Cleared May 18, 1998

Chemistry · 45d

Cleared May 12, 1998

Chemistry · 39d

Cleared Oct 03, 1995

ABBOTT IMX PROLACTIN(MODIFICATION)

Chemistry · 77d

Cleared Sep 25, 1995

ABBOTT AXSYM PROLACTIN(MODIFICATION)

Chemistry · 69d

Cleared Mar 23, 1995

Chemistry · 237d

Cleared Jul 18, 1994

ABBOTT PRISM ANALYZER

Chemistry · 138d

Cleared Jul 10, 1990

IMX ULTRASENTITIVE HTSH

Chemistry · 18d