Medical Device Manufacturer · US , Berwyn , PA

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

46 submissions · 46 cleared · Since 1987

Total

Cleared

Denied

Biotrol, USA, Inc. has 46 FDA 510(k) cleared chemistry devices. Based in Berwyn, US.

Historical record: 46 cleared submissions from 1987 to 1995.

Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.

Biotrol, USA, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

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

46 devices

1-12 of 46

Cleared Dec 06, 1995

VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT

K934014 · LRJ

General Hospital · 841d

Cleared May 26, 1993

BIOTROL AMYLASE CNPG3

K931141 · CIJ

Chemistry · 82d

Cleared Aug 03, 1992

BIOTROL BICARBONATE STANDARDS

K921855 · JIS

Chemistry · 108d

Cleared May 26, 1992

BIOTROL MAGNESIUM (MAGON)

BIOTROL PROTEIN MULTILEVEL STANDARDS

K910721 · JIS

Chemistry · 75d

Cleared Mar 11, 1991

BIOTROL LACTATE DEHYDROGENASE (L-P)

K905683 · CFJ

Chemistry · 82d

Cleared Feb 04, 1991

BIOTROL BILIRUBIN C & T CONTROL

K905280 · JJX

Chemistry · 73d

Cleared Aug 30, 1989

BIOTROL RUB-E.I.A. TEST G

K894544 · LFX

Microbiology · 41d

Cleared Aug 10, 1989

BIOTROL CALCIUM MONOREACTIF

K891061 · CJY

Chemistry · 162d

Cleared Apr 10, 1989

BIOTROL CHEMISTRY URINE CONTROL

K891286 · JJW

Chemistry · 32d

Cleared Mar 21, 1989

BIOTROL URINE PROTEINS REAGENT

K890846 · JIR

Chemistry · 28d

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

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

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