Bio-Tek Instruments, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 37
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K973609 | IDA-4 AND IPT-MC | December 18, 1997 |
| K971273 | INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF | October 8, 1997 |
| K961862 | MODELS IDA-2 PLUS AND IPT-1 | February 26, 1997 |
| K954391 | MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER | November 17, 1995 |
| K953710 | ELX808 AUTOMATED MICROPLATE READERS | October 25, 1995 |
| K953572 | ELX800UV | October 19, 1995 |
| K950104 | ELX800 AND EL800 AUTOMATED MICROPLATE READERS | March 21, 1995 |
| K942923 | CERES 900C & CERES UV900C | February 6, 1995 |
| K944257 | LIONHEART 3 MULTI-PARAMETER SIMULATOR | September 21, 1994 |
| K933519 | INDEX SPO2 SIMULATOR | September 1, 1994 |
| K933548 | ELS 1000 | October 29, 1993 |
| K925625 | OMNI | August 19, 1993 |
| K921074 | BP PUMP | October 9, 1992 |
| K914906 | AUTO EIA MICROPLATE READ MODEL CERES 900 W/VAR OPT | November 27, 1991 |
| K903966 | EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 | June 19, 1991 |
| K911438 | TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE | May 23, 1991 |
| K904159 | DEFIBRILLATOR ANALYZER MODEL QED-5 | March 18, 1991 |
| K901059 | AUTOMATED EIA MICROPLATE READER MODELS EL340/340I | April 9, 1990 |
| K901027 | AUTOMATED EIA MICROPLATE READER MODELS EL312/312I | April 9, 1990 |
| K900579 | AUTOREADER CALIBRATION TEST PLATE | February 27, 1990 |