510(k) Report

FDA product code · Clinical toxicology

Radioimmunoassay, Diphenylhydantoin

DLPClass II21 CFR 862.3350510(k) required5 decisions since 19770 recalls

5 FDA decisions since 1977. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, clinical toxicology panel

Twenty years of DLP at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · DLP

FDA has decided no DLP device since 2007.

Median 510(k) review, days · DLP

Too few DLP 510(k)s in any year since 2007 to give a median.

Recalls per year · DLP

No recall names DLP since 2007.

Adverse event reports per year · DLP

No MAUDE report names DLP since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — DLP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DLP? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

What has FDA decided in DLP lately?

  • K894527FPR Phenytoin KitColony Laboratories, Inc. · 1989
  • K811775Kallestad Antisera to PhenytoinKallestad Laboratories, Inc. · 1981
  • K792640Fluoromatic Phenytoin FiaBio-Rad · 1980
  • K791896Centria Phenytoin Ria Test SetVentrex Laboratories, Inc. · 1979
  • K770779Phenytoin Ria KitAmersham Corp. · 1977

All 5 DLP decisions →

Related product codes

Other codes under 21 CFR 862.3350.

MOJ Fluorescence Polarization Immunoassay…DPE Thin Layer Chromatography, DiphenylhydantoinORI Levetiracetam AssayOTF Gabapentin AssayLGR Fluorescence Polarization Immunoassay…DIP Enzyme Immunoassay, DiphenylhydantoinDKH Gas Chromatography, DiphenylhydantoinLDC U.V. Spectrometry, DiphenylhydantoinMSL System, Test, TopiramateeLFO Nephelometric Inhibition Immunoassay…NWM Immunoassay, Anti-Seizure DrugORH Lamotrigine Assay