# Bio-Tek Instruments, Inc.

- Location (FDA's records): Winooski, VT
- FDA decisions: 37 (1980–1997): 37 510(k) clearances
- Product codes: JJQ (14), JTC (3), FRN (2), DRL (2), DQA (2), DXN (1), DTC (1), JJE (1), GEX (1), IMJ (1), DRS (1), DPS (1)
- Predicates its devices cite: 8 (4 its own); citations of its devices by later devices: 11 (4 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Dynatech/Nevada, Inc.: 2 (https://510kreport.com/company/dynatech-nevada)
- Hogan & Hartson: 1 (https://510kreport.com/company/hogan-hartson)
- Clinical Dynamics Corp.: 1 (https://510kreport.com/company/clinical-dynamics)

## Firms that cite its devices most
- Dade Behring, Inc.: 1 (https://510kreport.com/company/dade-behring)
- Roche Molecular Systems, Inc.: 1 (https://510kreport.com/company/roche-molecular-systems)
- Masimo Corporation: 1 (https://510kreport.com/company/masimo)
- Fluke Biomedical: 1 (https://510kreport.com/company/fluke-biomedical)
- Astoria-Pacific, Inc.: 1 (https://510kreport.com/company/astoria-pacific)
- Dni Nevada, Inc.: 1 (https://510kreport.com/company/dni-nevada)
- Datrend Systems, Inc.: 1 (https://510kreport.com/company/datrend-systems)

## Its most-cited devices
- K903966: External Pacemaker Analyzer Model Pma-1 (1991), cited by 2
- K961862: Models Ida-2 Plus and Ipt-1 (1997), cited by 2
- K933519: Index SPO2 Simulator (1994), cited by 2
- K950104: ELX800 and EL800 Automated Microplate Readers (1995), cited by 1
- K904159: Defibrillator Analyzer Model Qed-5 (1991), cited by 1
- K842085: Automated Eia Microplate Reader EL310 (1984), cited by 1

## Recent decisions
- K973609: Ida-4 and Ipt-MC (Dec 18, 1997)
- K971273: Index 2E, Index 2F, Index 2EF, Cardiosat 100E, Cardiosat 100F, Cardiosat 100EF (Oct 8, 1997)
- K961862: Models Ida-2 Plus and Ipt-1 (Feb 26, 1997)
- K954391: Models Qed-6, 6M and 6H Defibrillator Analyzer with Optional Universal Pacemaker Load Adapter (Nov 17, 1995)
- K953710: ELX808 Automated Microplate Readers (Oct 25, 1995)
- K953572: ELX800UV (Oct 19, 1995)
- K950104: ELX800 and EL800 Automated Microplate Readers (Mar 21, 1995)
- K942923: Ceres 900C & Ceres UV900C (Feb 6, 1995)

Source page: https://510kreport.com/company/bio-tek-instruments