Medical Device Manufacturer · US , Mchenry , IL

Radiometer America, Inc. - FDA 510(k) Cleared Devices

50 submissions · 50 cleared · Since 1983

50

Total

50

Cleared

0

Denied

FDA 510(k) Regulatory Record - Radiometer America, Inc. Microbiology ✕

9 devices

1-9 of 9

Cleared Oct 07, 1995

Microbiology · 222d

Cleared Oct 07, 1995

HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE

Microbiology · 222d

Cleared Jul 13, 1995

SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES

Microbiology · 569d

Cleared Feb 24, 1995

SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP

Microbiology · 151d

Cleared Mar 29, 1994

SENSI-CAL AMCO AEPA-1

Microbiology · 131d

Cleared Mar 09, 1993

SENSITITRE SUSCEPTIBILITY PLATES

Microbiology · 258d

Cleared Sep 22, 1992

MICROBACT SOLID PLATE SYSTEMS

Microbiology · 98d

Cleared Aug 31, 1989

SENSITITRE INDOLE REAGENT

Microbiology · 35d

Cleared Jun 09, 1989

SENSITITRE AUTO ID PLATE AP80

Microbiology · 154d