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Aim-V (R) Medium, Model 087-0112

by Invitrogen Corporation

510(k) K022086

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 · Traditional NumberK022086 Date23 Dec 2002ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2543-2018 FDA Class II initiated 10 May 2018

    It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media.

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  • Withdrawn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
NDS
Device Class
Class II
Regulation
21 CFR Part 876.5885
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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