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Modification to Synchron Control

by Beckman Coulter, Inc.

510(k) K013235

Modification to Synchron Control is a Class I device made by Beckman Coulter, Inc., cleared under FDA 510(k) K013235 on 16 Oct 2001, active as of 22 Oct 2026.

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK013235 Date16 Oct 2001ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-1151-04 FDA Unclassified (pre-2012) initiated 1 Apr 2003 on shared 510(k) K013235

    The quality control samples for Vancomycin would not recover correctly when compared to the S.I. unit values listed in the incorrectly printed product insert. The incorrectly printed values were higher than they should be by a factor of 3 (three).

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

2 dated events

  1. Cleared FDA 510(k) K013235
  2. Recall initiated FDA recalls Z-1151-04

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  • Withdrawn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
JJY
Device class
Class I
Regulation
21 CFR Part 862.1660
Advisory committee
Clinical Chemistry
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code JJY (Multi-Analyte Controls, All Kinds (Assayed)).

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