510(k) Report

510(k) · Cleared

Cleared

DU Pont Phenytoin Assay and Calibrator

K863888510(k) TraditionalCleared Nov 5, 198630-day reviewClass II21 CFR 862.3250

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

E.I. Dupont DE Nemours & Co., Inc. · DIR Free Radical Assay, Cocaine

Cleared on Nov 5, 1986 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 5, 1986
Review
30 days
Class
Class II
Product code
DIR
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K863888Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DIR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All DIR devices

DIR Free Radical Assay, Cocaine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DIR

FDA has decided no DIR device since 2007.

Median 510(k) review, days · DIR

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

Recalls per year · DIR

No recall names DIR since 2007.

Adverse event reports per year · DIR

No MAUDE report names DIR 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—

More from E.I. Dupont DE Nemours & Co., Inc.

253 FDA decisions under this applicant name. See the company

  • K951851Alliance Cytomegalovirus Immediate Early Antigen Direct Immunofluorescence AssayE.I. Dupont DE Nemours & Co., Inc. · 1996
  • K953724Cronex Radiation Therapy CassetteE.I. Dupont DE Nemours & Co., Inc. · 1995
  • K953725Cronex Radiation Therapy Verification CassetteE.I. Dupont DE Nemours & Co., Inc. · 1995
  • K951441Dupont Aca Digoxin (DGN a) MethodE.I. Dupont DE Nemours & Co., Inc. · 1995
  • K950137Urine Barbiturates Screen Flex (TM) Reagent CartridgeE.I. Dupont DE Nemours & Co., Inc. · 1995

https://510kreport.com/device/K863888 · printed Nov 6, 2026

Cite this page

510(k) Report. “K863888: DU Pont Phenytoin Assay and Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K863888

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026