Skip to content

Innofluor Vancomycin Calibrator Set

by Innotron of Oregon, Inc.

510(k) K872644

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK872644 Date21 Jul 1987ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0297-2012 FDA Unclassified (pre-2012) initiated 8 Jun 2011

    Complaint from the sole distributor that the third party control material is recovering high, and outside the published range.

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  • Withdrawn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
DLJ
Device Class
Class II
Regulation
21 CFR Part 862.3200
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Other devices from Innotron of Oregon, Inc.

See all devices from Innotron of Oregon, Inc. →