Bio-Tek Instruments, Inc.
Mchenry, IL, US
Bio-Tek Instruments, Inc. appears in FDA device records in Mchenry, IL. FDA records list 37 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 37
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 37 510(k) clearances for Bio-Tek Instruments, Inc. between 1980 and 1997. The busiest year on record is 1995, with 5. The most recent is 1997, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 2 |
| 1981 | 1 |
| 1983 | 2 |
| 1984 | 1 |
| 1985 | 3 |
| 1986 | 2 |
| 1987 | 1 |
| 1988 | 1 |
| 1989 | 4 |
| 1990 | 3 |
| 1991 | 4 |
| 1992 | 1 |
| 1993 | 2 |
| 1994 | 2 |
| 1995 | 5 |
| 1997 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K973609 | IDA-4 AND IPT-MC | FRN | Substantially Equivalent - Subject to Tracking Reg. | |
| K971273 | INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF | DQA | Substantially Equivalent | |
| K961862 | MODELS IDA-2 PLUS AND IPT-1 | FRN | Substantially Equivalent - Subject to Tracking Reg. | |
| K954391 | MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER | DRL | Substantially Equivalent | |
| K953710 | ELX808 AUTOMATED MICROPLATE READERS | JJQ | Substantially Equivalent | |
| K953572 | ELX800UV | JJQ | Substantially Equivalent | |
| K950104 | ELX800 AND EL800 AUTOMATED MICROPLATE READERS | JJQ | Substantially Equivalent | |
| K942923 | CERES 900C & CERES UV900C | JJQ | Substantially Equivalent | |
| K944257 | LIONHEART 3 MULTI-PARAMETER SIMULATOR | DRT | Substantially Equivalent | |
| K933519 | INDEX SPO2 SIMULATOR | DQA | Substantially Equivalent | |
| K933548 | ELS 1000 | JJE | Substantially Equivalent | |
| K925625 | OMNI | JJQ | Substantially Equivalent | |
| K921074 | BP PUMP | DXN | Substantially Equivalent | |
| K914906 | AUTO EIA MICROPLATE READ MODEL CERES 900 W/VAR OPT | JJQ | Substantially Equivalent | |
| K903966 | EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 | DTC | Substantially Equivalent | |
| K911438 | TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE | JJQ | Substantially Equivalent | |
| K904159 | DEFIBRILLATOR ANALYZER MODEL QED-5 | DRL | Substantially Equivalent | |
| K901059 | AUTOMATED EIA MICROPLATE READER MODELS EL340/340I | JJQ | Substantially Equivalent | |
| K901027 | AUTOMATED EIA MICROPLATE READER MODELS EL312/312I | JJQ | Substantially Equivalent | |
| K900579 | AUTOREADER CALIBRATION TEST PLATE | JJQ | Substantially Equivalent | |
| K893660 | ECG SIMULATOR MODEL ECGPLUS | DPS | Substantially Equivalent | |
| K893659 | ELECTROSURGERY ANALYZER RF302 | GEI | Substantially Equivalent | |
| K890854 | EIA READER MODEL EL301 | JJQ | Substantially Equivalent | |
| K884124 | AUTOMATED EIA READER MODEL EL311 | JJQ | Substantially Equivalent | |
| K884125 | BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403 | JTC | Substantially Equivalent | |
| K871619 | LPM-1 (LASER POWER METER) | GEX | Substantially Equivalent | |
| K862932 | THE BIO-TEK UW-II | IMJ | Substantially Equivalent | |
| K862344 | GOULD XCALIBER | DRS | Substantially Equivalent | |
| K853760 | ADULT VENTILATOR TESTER VT-1 | CBK | Substantially Equivalent | |
| K853920 | BIO-TEK EL 401 HANDHELD MICROPLATE WASHER | JTC | Substantially Equivalent | |
| K850249 | BIO-TEK AUTOMATED MICROPLATE WASHER EL402 | JTC | Substantially Equivalent | |
| K842085 | AUTOMATED EIA MICROPLATE READER EL310 | JJQ | Substantially Equivalent | |
| K831522 | BIO-TEK PERCENT OXYGEN MONITOR 74222 | CCL | Substantially Equivalent | |
| K837605 | MV/CM2 NUMBER X74294 MODEL NUMBER 74229 | Substantially Equivalent | ||
| K810363 | EAR OXIMETER | DPZ | Substantially Equivalent | |
| K803030 | THE BIO-TEK CHROMOSCAN | JJQ | Substantially Equivalent | |
| K800591 | CONTOUROGRAPH M-500 | LDK | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- DTCAnalyzer, Pacemaker Generator Function
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- JTCDevice, Microtiter Diluting/Dispensing
- LDKDevice, Sensing, Optical Contour
- IMJDiathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
- DPSElectrocardiograph
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- DQAOximeter
- DPZOximeter, Ear
- GEXPowered Laser Surgical Instrument
- FRNPump, Infusion
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- DRLTester, Defibrillator
- DRSTransducer, Blood-Pressure, Extravascular
- CBKVentilator, Continuous, Facility Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain