510(k) Report

FDA applicant

Thermo Biostar, Inc.

Louisville, CO5 decisions2002–20041 recall

FDA records 5 decisions for Thermo Biostar, Inc. (Louisville, CO) from 2002 to 2004: 5 510(k) clearances. Most are in product codes LJC (Enzyme Linked Immunoabsorbent Assay…) and PSZ (Devices Detecting Influenza A, B, And C Virus…). Its devices cite 5 predicates, 1 of them its own earlier devices. 1 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, microbiology panel, where it files most

How often FDA has decided Thermo Biostar, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Thermo Biostar, Inc. since 2007.

Recalls per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Thermo Biostar, Inc.’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

Which product codes does it file in?

  • LJCEnzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)1decision
  • PSZDevices Detecting Influenza A, B, And C Virus Antigens1decision
  • GOGAntisera, Cf, Poliovirus 1-31decision
  • GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus1decision
  • LIRAntigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae1decision

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 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.

  • K023556Flu Oia a/B Test KitThermo Biostar, Inc. · 20033cite it
  • K021172RSV OiaThermo Biostar, Inc. · 20021cites it
  • K023779RSV OiaThermo Biostar, Inc. · 20031cites it

What has FDA decided for it lately?

  • K032330CT OIAThermo Biostar, Inc. · 2004
  • K023947GC OIAThermo Biostar, Inc. · 2003
  • K023556Flu Oia a/B Test KitThermo Biostar, Inc. · 20031 recall
  • K023779RSV OiaThermo Biostar, Inc. · 2003
  • K021172RSV OiaThermo Biostar, Inc. · 2002

All 5 as Thermo Biostar, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K023556BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO…Jul 2, 2008

Other applicant names beginning “Thermo”

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

Thermo Fisher Scientific 65Thermo Electron OY 14Thermo Dma, Inc. 4Thermo Temp, Inc. 4Thermo Fisher Scientific (Oxoid Ltd.) 3Thermo Orion 3Thermo Bioanalysis Corp. 2Thermo Fisher Scientific (Nalge Nunc Intl) 1Thermo-Mold Medical Products, Inc. 1Thermo Fisher Scientific (Life Technologies Holdin 1Thermo Forma, Inc. 1Thermo Body Wrap Systems, Inc. 1