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Actalyke Activated Clotting Time Test System/Clotting Time Tubes/Whole Blood Qc Kit/Actalyke Electronic Clotting Tube

by Array Medical, Inc.

510(k) K964609

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

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 NumberK964609 Date6 Mar 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 11 Oct 2026.

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  • Withdrawn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
JBP
Device Class
Class II
Regulation
21 CFR Part 864.7140
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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