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Hemocue Hemotrol

by Direct Solutions 510(k)

Active United States

510(k) K964052

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK964052 Date6 Nov 1996ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0515-2019 FDA Class II initiated 18 Oct 2018
    • Terminated Z-0514-2019 FDA Class II initiated 18 Oct 2018

    Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values

Specification

510(k)

510(k) Number
FDA Product Code
GGM
Device Class
Class II
Regulation
21 CFR Part 864.8625
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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