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Qbc System Mchc

by Bd Becton Dickinson Vacutainer Systems Preanalytic 510(k)

Active United States

510(k) K904675

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK904675 Date2 Nov 1990ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 11 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JPJ
Device Class
Class II
Regulation
21 CFR Part 864.5300
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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