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Sta - Liatest Vwf Test Kit

by American Bioproducts Co.

510(k) K962675

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 NumberK962675 Date25 Oct 1996ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0951-2013 FDA Class II initiated 28 Jan 2013

    Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.

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  • Withdrawn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
GJT
Device Class
Class II
Regulation
21 CFR Part 864.7290
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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