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Axsym Gentamicin

by Abbott Mfg., Inc.

510(k) K935376

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 NumberK935376 Date21 Jun 1994ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0930-2008 FDA Unclassified (pre-2012) initiated 26 Oct 2007

    Incorrect Results -- Through evaluation of stability, Abbott have found a decrease in the calibrator A to F span with these reagents lots, which may produce the following results: - Printed Error Code "SPAN LESS THAN MIN SPAN" - Controls out of range. When a control is out of range, patient results should not be reported.

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  • Withdrawn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
LCD
Device Class
Class II
Regulation
21 CFR Part 862.3450
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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