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Imx Folate

by Abbott Mfg., Inc.

510(k) K943691

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 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 NumberK943691 Date23 Mar 1995ClearedStatusActive

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-0370-04 FDA Unclassified (pre-2012) initiated 16 Dec 2003 on shared 510(k) K943691
    • Terminated Z-0369-04 FDA Unclassified (pre-2012) initiated 16 Dec 2003 on shared 510(k) K943691
    • Terminated Z-0372-04 FDA Unclassified (pre-2012) initiated 16 Dec 2003 on shared 510(k) K943691
    • Terminated Z-0368-04 FDA Unclassified (pre-2012) initiated 16 Dec 2003 on shared 510(k) K943691
    • Terminated Z-0371-04 FDA Unclassified (pre-2012) initiated 16 Dec 2003 on shared 510(k) K943691

    The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected 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  • Withdrawn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
CGN
Device Class
Class II
Regulation
21 CFR Part 862.1295
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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