510(k) Report

FDA applicant

Epitope, Inc.

Beaverton, OR2 decisions1997–19980 recalls

FDA records 2 decisions for Epitope, Inc. (Beaverton, OR) from 1997 to 1998: 2 510(k) clearances. All are in product code PJD (Oral Fluid Drugs Of Abuse And Alcohol Test…). Its devices cite 1 predicate, 1 of them its own earlier devices. 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 Epitope, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Epitope, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Epitope, 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 Device2decisions

Who builds on its devices?

Later devices cite its devices 4 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.

  • K970357EpiscreenEpitope, Inc. · 19973cite it
  • K973395Episcreen Oral Specimen Collection DeviceEpitope, Inc. · 19981cites it

What has FDA decided for it lately?

  • K973395Episcreen Oral Specimen Collection DeviceEpitope, Inc. · 1998
  • K970357EpiscreenEpitope, Inc. · 1997

All 2 as Epitope, Inc. →

Other applicant names beginning “Epitope”

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

Epitope Diagnostics, Inc. 1