Bio-Tek Instruments, Inc.
Medical device manufacturer in Winooski, VT.
37510(k) clearances
0PMA approvals
0recalls
Device types
- JJQ Colorimeter, Photometer, Spectrophotometer… 14
- JTC Device, Microtiter Diluting/Dispensing 3
- FRN Pump, Infusion 2
- DQA Oximeter 2
- DRL Tester, Defibrillator 2
- CBK Ventilator, Continuous, Facility Use 1
- DRS Transducer, Blood-Pressure, Extravascular 1
- IMJ Diathermy, Shortwave, For Use In Applying… 1
- GEX Powered Laser Surgical Instrument 1
- GEI Electrosurgical, Cutting & Coagulation &… 1
- DPS Electrocardiograph 1
- CCL Analyzer, Gas, Oxygen, Gaseous-Phase 1
- DTC Analyzer, Pacemaker Generator Function 1
- DXN System, Measurement, Blood-Pressure… 1
- JJE Analyzer, Chemistry (Photometric… 1
- DPZ Oximeter, Ear 1
- DRT Monitor, Cardiac (Incl. Cardiotachometer &… 1
- LDK Device, Sensing, Optical Contour 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K973609 | IDA-4 and Ipt-McFRN · Traditional | 12/18/1997ST |
| K971273 | Index 2E, Index 2F, Index 2EF, Cardiosat 100E, Cardiosat 100F, Cardiosat 100EFDQA · Traditional | 10/08/1997SE |
| K961862 | Models IDA-2 Plus and IPT-1FRN · Traditional | 02/26/1997ST |
| K954391 | Models QED-6, 6M and 6H Defibrillator Analyzer with Optional Universal Pacemaker Load…DRL · Traditional | 11/17/1995SE |
| K953710 | ELX808 Automated Microplate ReadersJJQ · Traditional | 10/25/1995SE |
| K953572 | ELX800UVJJQ · Traditional | 10/19/1995SE |
| K950104 | ELX800 and EL800 Automated Microplate ReadersJJQ · Traditional | 03/21/1995SE |
| K942923 | Ceres 900C & Ceres UV900CJJQ · Traditional | 02/06/1995SE |
| K944257 | Lionheart 3 Multi-Parameter SimulatorDRT · Traditional | 09/21/1994SE |
| K933519 | Index SPO2 SimulatorDQA · Traditional | 09/01/1994SE |
| K933548 | Els 1000JJE · Traditional | 10/29/1993SE |
| K925625 | OmniJJQ · Traditional | 08/19/1993SE |
| K921074 | BP PumpDXN · Traditional | 10/09/1992SE |
| K914906 | Auto Eia Microplate Read Model Ceres 900 W/Var OptJJQ · Traditional | 11/27/1991SE |
| K903966 | External Pacemaker Analyzer Model PMA-1DTC · Traditional | 06/19/1991SE |
| K911438 | Turbo Accelerator W/Clin Diag Software CartridgeJJQ · Traditional | 05/23/1991SE |
| K904159 | Defibrillator Analyzer Model QED-5DRL · Traditional | 03/18/1991SE |
| K901059 | Automated Eia Microplate Reader Models EL340/340IJJQ · Traditional | 04/09/1990SE |
| K901027 | Automated Eia Microplate Reader Models EL312/312IJJQ · Traditional | 04/09/1990SE |
| K900579 | Autoreader Calibration Test PlateJJQ · Traditional | 02/27/1990SE |
| K893660 | ECG Simulator Model EcgplusDPS · Traditional | 12/05/1989SE |
| K893659 | Electrosurgery Analyzer RF302GEI · Traditional | 07/14/1989SE |
| K890854 | Eia Reader Model EL301JJQ · Traditional | 03/16/1989SE |
| K884124 | Automated Eia Reader Model EL311JJQ · Traditional | 01/03/1989SE |
| K884125 | Bio-Tek Automated Microplate Washer Model EL403JTC · Traditional | 12/02/1988SE |
| K871619 | LPM-1 (Laser Power Meter)GEX · Traditional | 07/28/1987SE |
| K862932 | The Bio-Tek Uw-IiIMJ · Traditional | 09/25/1986SE |
| K862344 | Gould XcaliberDRS · Traditional | 08/06/1986SE |
| K853760 | Adult Ventilator Tester VT-1CBK · Traditional | 12/03/1985SE |
| K853920 | Bio-Tek El 401 Handheld Microplate WasherJTC · Traditional | 10/22/1985SE |
| K850249 | Bio-Tek Automated Microplate Washer EL402JTC · Traditional | 03/13/1985SE |
| K842085 | Automated Eia Microplate Reader EL310JJQ · Traditional | 06/11/1984SE |
| K831522 | Bio-Tek Percent Oxygen Monitor 74222CCL · Traditional | 09/12/1983SE |
| K837605 | MV/CM2 Number X74294 Model Number 74229 · Traditional | 06/28/1983SE |
| K810363 | Ear OximeterDPZ · Traditional | 02/27/1981SE |
| K803030 | The Bio-Tek ChromoscanJJQ · Traditional | 12/22/1980SE |
| K800591 | Contourograph M-500LDK · Traditional | 04/02/1980SE |