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Diacrom Heparin

by Wellcome Diagnostics

510(k) K832373

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK832373 Date29 Sep 1983ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
KFF
Device Class
Class II
Regulation
21 CFR Part 864.7525
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

Diacrom Heparin is a heparin assay used for the quantitative determination of heparin in human plasma. It functions as a diagnostic test within the field of hematology.

This device is regulated under FDA 510(k) clearance K832373 and is classified as a class 2 medical device. It is identified by product code KFF and is subject to regulation number 864.7525.

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