510(k) Report

FDA applicant

Microprobe Corp.

Bothell, WA6 decisions1992–19931 recall

FDA records 6 decisions for Microprobe Corp. (Bothell, WA) from 1992 to 1993: 6 510(k) clearances. Most are in product codes MLA (Dna Probe, Yeast) and JQW (Station, Pipetting And Diluting, For Clinical…). 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 Microprobe Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Microprobe Corp. since 2007.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Microprobe 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

Which product codes does it file in?

  • MLADna Probe, Yeast2decisions
  • JQWStation, Pipetting And Diluting, For Clinical Use1decision
  • MJKDna Probe, Trichomonas Vaginalis1decision
  • LIODevice, Specimen Collection1decision
  • MJMDna Probe, Gardnerella Vaginalis1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K923133Affirm/VP Ident.Test G.Vaginalis & T.VaginalisMicroprobe Corp. · 19921cites it

What has FDA decided for it lately?

  • K931151Affirm (TM) Vpiii Microbial Ident Test for CandidaMicroprobe Corp. · 1993
  • K931374Affirm Vpiii Microbial Identification TestMicroprobe Corp. · 19931 recall
  • K922457Affirm VP Microbial ID Test for Trichomonas VaginaMicroprobe Corp. · 1992
  • K923133Affirm/VP Ident.Test G.Vaginalis & T.VaginalisMicroprobe Corp. · 1992
  • K923268Affirm ProcessorMicroprobe Corp. · 1992
  • K920536Affirm VP Sample Collection SetMicroprobe Corp. · 1992

All 6 as Microprobe Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K931374BD AffirM VPIII Microbial Identification TestAug 27, 2015Class II