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Bio-Tek Instruments, Inc.

FDA 510(k) & PMA Approved Devices — 37 products

Total Devices37
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K973609 IDA-4 AND IPT-MCFRN1997-12-18 View
510(k) K971273 INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EFDQA1997-10-08 View
510(k) K961862 MODELS IDA-2 PLUS AND IPT-1FRN1997-02-26 View
510(k) K954391 MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTERDRL1995-11-17 View
510(k) K953710 ELX808 AUTOMATED MICROPLATE READERSJJQ1995-10-25 View
510(k) K953572 ELX800UVJJQ1995-10-19 View
510(k) K950104 ELX800 AND EL800 AUTOMATED MICROPLATE READERSJJQ1995-03-21 View
510(k) K942923 CERES 900C & CERES UV900CJJQ1995-02-06 View
510(k) K944257 LIONHEART 3 MULTI-PARAMETER SIMULATORDRT1994-09-21 View
510(k) K933519 INDEX SPO2 SIMULATORDQA1994-09-01 View
510(k) K933548 ELS 1000JJE1993-10-29 View
510(k) K925625 OMNIJJQ1993-08-19 View
510(k) K921074 BP PUMPDXN1992-10-09 View
510(k) K914906 AUTO EIA MICROPLATE READ MODEL CERES 900 W/VAR OPTJJQ1991-11-27 View
510(k) K903966 EXTERNAL PACEMAKER ANALYZER MODEL PMA-1DTC1991-06-19 View
510(k) K911438 TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGEJJQ1991-05-23 View
510(k) K904159 DEFIBRILLATOR ANALYZER MODEL QED-5DRL1991-03-18 View
510(k) K901027 AUTOMATED EIA MICROPLATE READER MODELS EL312/312IJJQ1990-04-09 View
510(k) K901059 AUTOMATED EIA MICROPLATE READER MODELS EL340/340IJJQ1990-04-09 View
510(k) K900579 AUTOREADER CALIBRATION TEST PLATEJJQ1990-02-27 View
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