FDA applicant

Thermo Bioanalysis Corp.

Holliston, MA2 decisions1998–19980 recalls

FDA records 2 decisions for Thermo Bioanalysis Corp. (Holliston, MA) in 1998: 2 510(k) clearances. Most are in product codes CHL (Electrode Measurement, Blood-Gases (Pco2, Po2)…) and JIX (Calibrator, Multi-Analyte Mixture). No recall is 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 Thermo Bioanalysis Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Thermo Bioanalysis Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Thermo Bioanalysis Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Thermo”

FDA records each applicant name separately; these may or may not be the same firm.

Thermo Fisher Scientific 65 Thermo Electron OY 14 Thermo Biostar, Inc. 5 Thermo Dma, Inc. 4 Thermo Temp, Inc. 4 Thermo Fisher Scientific (Oxoid Ltd.) 3 Thermo Orion 3 Thermo Fisher Scientific (Nalge Nunc Intl) 1 Thermo-Mold Medical Products, Inc. 1 Thermo Fisher Scientific (Life Technologies Holdin 1 Thermo Forma, Inc. 1 Thermo Body Wrap Systems, Inc. 1

Thermo Bioanalysis Corp.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Thermo”