Company ยท US
Bio-Tek Instruments, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1997. Name variants (Inc, Corp, punctuation) are merged.
37510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 14 |
| JTC | Device, Microtiter Diluting/Dispensing | 3 |
| DQA | Oximeter | 2 |
| DRL | Tester, Defibrillator | 2 |
| FRN | Pump, Infusion | 2 |
| CBK | Ventilator, Continuous, Facility Use | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 |
| DPS | Electrocardiograph | 1 |
| DPZ | Oximeter, Ear | 1 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 |
| DTC | Analyzer, Pacemaker Generator Function | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| GEX | Powered Laser Surgical Instrument | 1 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 |
| LDK | Device, Sensing, Optical Contour | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 18, 1997 | K973609 | IDA-4 AND IPT-MC Bio-Tek Instruments, Inc. | FRN |
| Oct 8, 1997 | K971273 | INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF Bio-Tek Instruments, Inc. | DQA |
| Feb 26, 1997 | K961862 | MODELS IDA-2 PLUS AND IPT-1 Bio-Tek Instruments, Inc. | FRN |
| Nov 17, 1995 | K954391 | MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER Bio-Tek Instruments, Inc. | DRL |
| Oct 25, 1995 | K953710 | ELX808 AUTOMATED MICROPLATE READERS Bio-Tek Instruments, Inc. | JJQ |
| Oct 19, 1995 | K953572 | ELX800UV Bio-Tek Instruments, Inc. | JJQ |
| Mar 21, 1995 | K950104 | ELX800 AND EL800 AUTOMATED MICROPLATE READERS Bio-Tek Instruments, Inc. | JJQ |
| Feb 6, 1995 | K942923 | CERES 900C & CERES UV900C Bio-Tek Instruments, Inc. | JJQ |
| Sep 21, 1994 | K944257 | LIONHEART 3 MULTI-PARAMETER SIMULATOR Bio-Tek Instruments, Inc. | DRT |
| Sep 1, 1994 | K933519 | INDEX SPO2 SIMULATOR Bio-Tek Instruments, Inc. | DQA |
| Oct 29, 1993 | K933548 | ELS 1000 Bio-Tek Instruments, Inc. | JJE |
| Aug 19, 1993 | K925625 | OMNI Bio-Tek Instruments, Inc. | JJQ |
| Oct 9, 1992 | K921074 | BP PUMP Bio-Tek Instruments, Inc. | DXN |
| Nov 27, 1991 | K914906 | AUTO EIA MICROPLATE READ MODEL CERES 900 W/VAR OPT Bio-Tek Instruments, Inc. | JJQ |
| Jun 19, 1991 | K903966 | EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 Bio-Tek Instruments, Inc. | DTC |
| May 23, 1991 | K911438 | TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE Bio-Tek Instruments, Inc. | JJQ |
| Mar 18, 1991 | K904159 | DEFIBRILLATOR ANALYZER MODEL QED-5 Bio-Tek Instruments, Inc. | DRL |
| Apr 9, 1990 | K901059 | AUTOMATED EIA MICROPLATE READER MODELS EL340/340I Bio-Tek Instruments, Inc. | JJQ |
| Apr 9, 1990 | K901027 | AUTOMATED EIA MICROPLATE READER MODELS EL312/312I Bio-Tek Instruments, Inc. | JJQ |
| Feb 27, 1990 | K900579 | AUTOREADER CALIBRATION TEST PLATE Bio-Tek Instruments, Inc. | JJQ |
| Dec 5, 1989 | K893660 | ECG SIMULATOR MODEL ECGPLUS Bio-Tek Instruments, Inc. | DPS |
| Jul 14, 1989 | K893659 | ELECTROSURGERY ANALYZER RF302 Bio-Tek Instruments, Inc. | GEI |
| Mar 16, 1989 | K890854 | EIA READER MODEL EL301 Bio-Tek Instruments, Inc. | JJQ |
| Jan 3, 1989 | K884124 | AUTOMATED EIA READER MODEL EL311 Bio-Tek Instruments, Inc. | JJQ |
| Dec 2, 1988 | K884125 | BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403 Bio-Tek Instruments, Inc. | JTC |
| Jul 28, 1987 | K871619 | LPM-1 (LASER POWER METER) Bio-Tek Instruments, Inc. | GEX |
| Sep 25, 1986 | K862932 | THE BIO-TEK UW-II Bio-Tek Instruments, Inc. | IMJ |
| Aug 6, 1986 | K862344 | GOULD XCALIBER Bio-Tek Instruments, Inc. | DRS |
| Dec 3, 1985 | K853760 | ADULT VENTILATOR TESTER VT-1 Bio-Tek Instruments, Inc. | CBK |
| Oct 22, 1985 | K853920 | BIO-TEK EL 401 HANDHELD MICROPLATE WASHER Bio-Tek Instruments, Inc. | JTC |
| Mar 13, 1985 | K850249 | BIO-TEK AUTOMATED MICROPLATE WASHER EL402 Bio-Tek Instruments, Inc. | JTC |
| Jun 11, 1984 | K842085 | AUTOMATED EIA MICROPLATE READER EL310 Bio-Tek Instruments, Inc. | JJQ |
| Sep 12, 1983 | K831522 | BIO-TEK PERCENT OXYGEN MONITOR 74222 Bio-Tek Instruments, Inc. | CCL |
| Jun 28, 1983 | K837605 | MV/CM2 NUMBER X74294 MODEL NUMBER 74229 Bio-Tek Instruments, Inc. | |
| Feb 27, 1981 | K810363 | EAR OXIMETER Bio-Tek Instruments, Inc. | DPZ |
| Dec 22, 1980 | K803030 | THE BIO-TEK CHROMOSCAN Bio-Tek Instruments, Inc. | JJQ |
| Apr 2, 1980 | K800591 | CONTOUROGRAPH M-500 Bio-Tek Instruments, Inc. | LDK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||