Modification to Access Cea Reagents for Use on the Access Immunoassay Analyzer, Models 33200, 33205, 33209, 33206

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K991707 ↗

FDA Product Code

DHX

Models / Variants

33200

33205

33209

33206

Device Class

Class II

Regulation

21 CFR Part 866.6010

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Beckman Cholinesterase Reagent Kit

  Class I

  FDA 510(k) K893583 Active Cleared 15 Aug 1989

• P-Amylase Control

  Class I

  FDA 510(k) K935362 Active Cleared 27 Jan 1994

• Synchron Cx 7 Clinical Analyzer

  Class I

  FDA 510(k) K904219 Active Cleared 22 Oct 1990

• Synchron CX4-Ce

  Class I

  FDA 510(k) K904220 Active Cleared 15 Oct 1990