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Du Pont Drug Calibrator

by E.I. Dupont DE Nemours & Co., Inc.

510(k) K861786

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK861786 Date29 Jul 1986ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JIX
Device Class
Class II
Regulation
21 CFR Part 862.1150
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Du Pont Drug Calibrator is a Calibrator, Multi-Analyte Mixture (product code JIX), designed for use in clinical chemistry. It serves as a reference standard to calibrate and validate laboratory instruments and assays, ensuring accurate measurement of multiple analytes in patient samples.

This device is intended for single-use in clinical laboratory settings and has received FDA 510(k) clearance under the Special Controls regulation (862.1150). Supplied as a sterile, pre-measured mixture, it is classified as a Class II medical device and must comply with applicable manufacturing and quality standards. No additional regulatory markings beyond the FDA clearance are specified.

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