Medical Device Manufacturer · US , Berwyn , PA

Biotrol, USA, Inc. - FDA 510(k) Cleared Devices

46 submissions · 46 cleared · Since 1987

46

Total

46

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biotrol, USA, Inc. Chemistry ✕

42 devices

1-12 of 42

Cleared May 26, 1993

BIOTROL AMYLASE CNPG3

Chemistry · 82d

Cleared Aug 03, 1992

BIOTROL BICARBONATE STANDARDS

Chemistry · 108d

Cleared May 26, 1992

BIOTROL MAGNESIUM (MAGON)

Chemistry · 48d

Cleared Aug 12, 1991

BIOTROL UIBC REAGENT

Chemistry · 48d

Cleared May 06, 1991

BIOTROL PROTEIN MULTILEVEL STANDARDS

Chemistry · 75d

Cleared Mar 11, 1991

BIOTROL LACTATE DEHYDROGENASE (L-P)

Chemistry · 82d

Cleared Feb 04, 1991

BIOTROL BILIRUBIN C & T CONTROL

Chemistry · 73d

Cleared Aug 10, 1989

BIOTROL CALCIUM MONOREACTIF

Chemistry · 162d

Cleared Apr 10, 1989

BIOTROL CHEMISTRY URINE CONTROL

Chemistry · 32d

Cleared Mar 21, 1989

BIOTROL URINE PROTEINS REAGENT

Chemistry · 28d

Cleared Mar 08, 1989

BIOTROL IRON REAGENT

Chemistry · 42d

Cleared Feb 17, 1989

BIOTROL CHLORIDE

Chemistry · 45d

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