Beckman Cx Ammonia/Alcohol Control

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K934467 ↗

FDA Product Code

DKC

Device Class

Class I

Regulation

21 CFR Part 862.3280

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Beckman Direct Bilirubin Reagent

  Class II

  FDA 510(k) K934068 Active Cleared 26 Apr 1994

• Vigil Prx Chemistry Control

  Class I

  FDA 510(k) K936184 Active Cleared 15 Apr 1994

• Cx Phencyclidine Reagent for Synschron Cx System

  Unclassified

  FDA 510(k) K944605 Active Cleared 7 Dec 1994

• Synchron CX3 Delta

  Class I

  FDA 510(k) K942676 Active Cleared 2 Nov 1994

• Beckman Pancreatic Amylase (Pamy) Reagent

  Class II

  FDA 510(k) K934293 Active Cleared 6 Jul 1994

• Beckman Synchron Lactate Reagent

  Class I

  FDA 510(k) K934271 Active Cleared 9 Nov 1993

See all devices from Beckman-Diagnostic Systems Group →