Model 5500 Ceas

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K934977 ↗

FDA Product Code

CDF

Device Class

Class I

Regulation

21 CFR Part 862.1795

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Esa Plasma Free Metanephrine Analysis Kit

  Class I

  FDA 510(k) K032199 Active Cleared 30 Jan 2004

• Model 5500 Ceas

  Class I

  FDA 510(k) K963938 Active Cleared 26 Dec 1996

• Neurochemical Analyzer

  Class I

  FDA 510(k) K864729 Active Cleared 13 Apr 1987

• Coulochem II

  Class I

  FDA 510(k) K903231 Active Cleared 27 Sep 1990

• Model 5500 Coulochem Electrode Array System

  Class I

  FDA 510(k) K931148 Active Cleared 9 Jun 1993

• Leadcare Blood Lead Testing System

  Class II

  FDA 510(k) K971640 Active Cleared 9 Sep 1997