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Ptt-La Test Kit

by American Bioproducts Co.

510(k) K921684

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 NumberK921684 Date9 Jun 1992ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1419-05 FDA Unclassified (pre-2012) initiated 13 Apr 2005

    Variable clotting times observed with the PTT-LA, Lupus Anticoagulant-Sensitive APTT Reagent.

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  • Withdrawn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
GGW
Device Class
Class II
Regulation
21 CFR Part 864.7925
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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