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Idi-Mrsa

by Infectio Diagnostic (I.D.I.), Inc.

510(k) K033415

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 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK033415 Date18 Mar 2004ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1378-05 FDA Unclassified (pre-2012) initiated 22 Jul 2005 on shared 510(k) K033415

    A problem in the software has the potential to be associated with the incorrect reporting of sample results.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
NQX
Device Class
Class II
Regulation
21 CFR Part 866.1640
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Other devices from Infectio Diagnostic (I.D.I.), Inc.