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Dupont APC Blood Collection Container With Thromboplastin

by Dupont Medical Products

510(k) K942241

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 NumberK942241 Date18 Aug 1994ClearedStatusActive

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  • Withdrawn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
JKA
Device Class
Class II
Regulation
21 CFR Part 862.1675
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

This device is a blood collection container with thromboplastin, classified under the nomenclature for tubes, vials, systems, serum separators, and blood collection devices. It is designed for the collection and processing of blood specimens in clinical laboratory settings.

The device is supplied as a single-use container and was cleared via the FDA 510(k) process under K942241, with a decision of substantially equivalent granted on August 18, 1994. It is intended for use in clinical chemistry laboratories and is not MRI conditional or reusable; storage and handling should follow standard procedures for blood collection devices as indicated by its authorization and specifications.

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Questions

AI-generated answers, 22 Sep 2026

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

  • What is the Dupont APC Blood Collection Container with Thromboplastin used for?

    It is designed for the collection and processing of blood specimens in clinical laboratory settings, specifically intended for use in clinical chemistry laboratories to support diagnostic testing.

  • Is the Dupont APC Blood Collection Container with Thromboplastin reusable or single-use?

    The device is supplied as a single-use container and is not intended for reuse; it should be discarded after one use to maintain specimen integrity and prevent cross-contamination.

  • How was the Dupont APC Blood Collection Container with Thromboplastin cleared for market?

    It was cleared via the FDA 510(k) process under submission K942241, with a determination of substantial equivalence granted on August 18, 1994, based on its similarity to legally marketed predicate devices.

  • What storage and handling procedures should be followed for this device?

    Storage and handling should follow standard procedures for blood collection devices as indicated by its authorization and specifications, typically involving controlled temperature and protection from light and moisture until use.