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Prospect Shiga Toxin Microplate Assay

by Alexon - Trend, Inc.

510(k) K980507

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 NumberK980507 Date23 Apr 1998ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1373-04 FDA Unclassified (pre-2012) initiated 18 Jul 2002

    A potential contamination was noted in the conjugate in the ProSpecT Shiga Toxin E. coli Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged.

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  • Withdrawn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
GMZ
Device Class
Class I
Regulation
21 CFR Part 866.3255
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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