510(k) Report

FDA applicant

Osborn Laboratories, Inc.

Olathe, KS2 decisions1999–19991 recall

FDA records 2 decisions for Osborn Laboratories, Inc. (Olathe, KS) in 1999: 2 510(k) clearances. Most are in product codes PJD (Oral Fluid Drugs Of Abuse And Alcohol Test…) and LCP (Assay, Glycosylated Hemoglobin). Its devices cite 4 predicates, 0 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Osborn Laboratories, Inc. since 2007.

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Osborn Laboratories, 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?

  • PJDOral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device1decision
  • LCPAssay, Glycosylated Hemoglobin1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K984361Oral-Eze Oral Fluid Collection SystemOsborn Laboratories, Inc. · 19991cites it
  • K984529Hemochek Sample Collection KitOsborn Laboratories, Inc. · 19991cites it

What has FDA decided for it lately?

  • K984529Hemochek Sample Collection KitOsborn Laboratories, Inc. · 1999
  • K984361Oral-Eze Oral Fluid Collection SystemOsborn Laboratories, Inc. · 19991 recall

All 2 as Osborn Laboratories, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K984361Oral-Eze (R) Oral Fluid Collection System, manufactured by Capitol Vial, Inc., Auburn…Oct 7, 2011

Other applicant names beginning “Osborn”

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

Osborn Group, Inc. 4Osborn Medical Corp. 2