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Synchron Systems Direct Ldl Chloesterol Reagent and Calibrator

by Beckman Coulter, Inc.

510(k) K014103

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK014103 Date28 Jan 2002ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1099-04 FDA Unclassified (pre-2012) initiated 10 Feb 2003

    Expiration date on the reagent cartridges and kit box were incorrect in that they were about 6 months beyond the actual expiration date.

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  • Withdrawn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
MRR
Device Class
Class I
Regulation
21 CFR Part 862.1475
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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