Synermed Ir 500 Chemistry Analyzer

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K935662 ↗

FDA Product Code

JIQ

Device Class

Class I

Regulation

21 CFR Part 862.1645

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Amp Alkaline Phosphatase Reagent Kit

  Class II

  FDA 510(k) K931986 Active Cleared 8 Sep 1993

• Synermed 600 Nm Uric Acid Reagent Kit

  Class I

  FDA 510(k) K923414 Active Cleared 22 Sep 1992

• Synermed Ise Reagents

  Class II

  FDA 510(k) K941400 Active Cleared 26 Apr 1994

• Synermed Ggt Reagent Kit

  Class I

  FDA 510(k) K931958 Active Cleared 8 Sep 1993

• Synermed Direct Bilirubin Reagent Kit

  Class II

  FDA 510(k) K933026 Active Cleared 28 Oct 1993

• Synermed Near-Infrared Direct Bilirubin Reagent Kit

  Class II

  FDA 510(k) K973109 Active Cleared 25 Sep 1997

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