Synermed Alkaline Phosphatase Reagent Kit

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K904030 ↗

FDA Product Code

CJE

Device Class

Class II

Regulation

21 CFR Part 862.1050

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

See all devices from Synermed, Inc. →

• What is the intended use of the Synermed Alkaline Phosphatase Reagent Kit?

  This kit is designed as a test system to measure alkaline phosphatase or its isoenzymes in human serum or plasma samples. It is utilized by clinicians in the diagnosis and treatment of various medical conditions, specifically those affecting the liver, bone, parathyroid, and intestinal systems.

• What is the regulatory status of this reagent kit?

  The Synermed Alkaline Phosphatase Reagent Kit has received FDA 510(k) clearance. It was reviewed under the clinical chemistry advisory committee and determined to be substantially equivalent to existing devices for its intended use.

• What type of device is this according to its classification?

  This device is classified as a Class 2 medical device under regulation number 862.1050. It falls under the clinical chemistry medical specialty and is identified by the product code CJE, which corresponds to nitrophenylphosphate alkaline phosphatase or isoenzymes test systems.