Medical Device Manufacturer · US , Mchenry , IL

Bio-Tek Instruments, Inc. - FDA 510(k) Cleared Devices

37 submissions · 35 cleared · Since 1980

Recent clearances: IDA-4 AND IPT-MC, INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF, MODELS IDA-2 PLUS AND IPT-1

Total

Cleared

Denied

Bio-Tek Instruments, Inc. has 35 FDA 510(k) cleared medical devices. Based in Mchenry, US.

Historical record: 35 cleared submissions from 1980 to 1997. Primary specialty: Chemistry.

Browse the FDA 510(k) cleared devices submitted by Bio-Tek Instruments, Inc. Filter by specialty or product code using the sidebar.

Bio-Tek Instruments, 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 - Bio-Tek Instruments, Inc.

37 devices

1-12 of 37

Cleared Dec 18, 1997

IDA-4 AND IPT-MC

K973609 · FRN

General Hospital · 87d

Cleared Oct 08, 1997

INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF

K971273 · DQA

Anesthesiology · 184d

Cleared Feb 26, 1997

MODELS IDA-2 PLUS AND IPT-1

K961862 · FRN

General Hospital · 288d

Cleared Nov 17, 1995

MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL...

K954391 · DRL

Cardiovascular · 59d

Cleared Oct 25, 1995

ELX808 AUTOMATED MICROPLATE READERS

ELX800 AND EL800 AUTOMATED MICROPLATE READERS

K950104 · JJQ

Chemistry · 69d

Cleared Feb 06, 1995

CERES 900C & CERES UV900C

K942923 · JJQ

Chemistry · 230d

Cleared Sep 21, 1994

LIONHEART 3 MULTI-PARAMETER SIMULATOR

Anesthesiology · 408d

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Bio-Tek Instruments, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Bio-Tek Instruments, Inc.

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