510(k) Report

FDA applicant

Bio-Tek Instruments, Inc.

Winooski, VT37 decisions1980–19973 recalls

FDA records 37 decisions for Bio-Tek Instruments, Inc. (Winooski, VT) from 1980 to 1997: 37 510(k) clearances. Most are in product codes JJQ (Colorimeter, Photometer, Spectrophotometer For…) and JTC (Device, Microtiter Diluting/Dispensing). Its devices cite 8 predicates, 4 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Bio-Tek Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bio-Tek Instruments, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bio-Tek Instruments, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bio-Tek Instruments, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • JJQColorimeter, Photometer, Spectrophotometer For Clinical Use14decisions
  • JTCDevice, Microtiter Diluting/Dispensing3decisions
  • FRNPump, Infusion2decisions
  • DRLTester, Defibrillator2decisions
  • DQAOximeter2decisions
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive1decision

Also: DTC (1), JJE (1), GEX (1), IMJ (1), DRS (1), DPS (1).

Whose devices does it build on?

Its devices cite 8 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K903966External Pacemaker Analyzer Model Pma-1Bio-Tek Instruments, Inc. · 19912cite it
  • K961862Models Ida-2 Plus and Ipt-1Bio-Tek Instruments, Inc. · 19972cite it
  • K933519Index SPO2 SimulatorBio-Tek Instruments, Inc. · 19942cite it
  • K950104ELX800 and EL800 Automated Microplate ReadersBio-Tek Instruments, Inc. · 19951cites it
  • K904159Defibrillator Analyzer Model Qed-5Bio-Tek Instruments, Inc. · 19911cites it
  • K842085Automated Eia Microplate Reader EL310Bio-Tek Instruments, Inc. · 19841cites it

What has FDA decided for it lately?

  • K973609Ida-4 and Ipt-MCBio-Tek Instruments, Inc. · 1997
  • K971273Index 2E, Index 2F, Index 2EF, Cardiosat 100E, Cardiosat 100F, Cardiosat 100EFBio-Tek Instruments, Inc. · 1997
  • K961862Models Ida-2 Plus and Ipt-1Bio-Tek Instruments, Inc. · 1997
  • K954391Models Qed-6, 6M and 6H Defibrillator Analyzer with Optional Universal Pacemaker Load AdapterBio-Tek Instruments, Inc. · 1995
  • K953710ELX808 Automated Microplate ReadersBio-Tek Instruments, Inc. · 19951 recall
  • K953572ELX800UVBio-Tek Instruments, Inc. · 1995
  • K950104ELX800 and EL800 Automated Microplate ReadersBio-Tek Instruments, Inc. · 19951 recall
  • K942923Ceres 900C & Ceres UV900CBio-Tek Instruments, Inc. · 1995

All 37 as Bio-Tek Instruments, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K950104BioTek brand Automated Microplate Reader; model ELx800, Roche catalog number 21045059001.Feb 15, 2005
  • K953710BioTek brand Automated Microplate Reader; model ELx808, Roche catalog number 03145387001.Feb 15, 2005
  • K884125Version 7 Software for wash program on Bio Tek Automated Microplate Washer Model ELx50…May 20, 2004