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Qca (Version 3.1)

by Cell Analysis, Inc.

510(k) K031363

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK031363 Date5 Feb 2004ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1040-2009 FDA Unclassified (pre-2012) initiated 6 Nov 2008

    A change in the software to open up the software architecture to include other analytes other than Estrogen Receptor was made without FDA review and approval.

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  • Withdrawn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
NQN
Device Class
Class II
Regulation
21 CFR Part 864.1860
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent