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Synchron Systems Ammonia (Amm) Reagent

by Beckman Coulter, Inc. 510(k)

Active United States

510(k) K984402

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK984402 Date29 Jan 1999ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1432-2012 FDA Unclassified (pre-2012) initiated 26 Mar 2009

    The Ammonia Reagent lot M808278 may fail calibration or cause a low shift in Quality Control recovery on some SYNCHRON Systems.

Specification

510(k)

510(k) Number
FDA Product Code
JIF
Device Class
Class I
Regulation
21 CFR Part 862.1065
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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