Synermed® ISE720

• FDA 510(k) K952179 decided 20 Jun 1995 Active
• FDA GUDID UDI-DI 05060500091057 listed 20 Sep 2016 Listed

1. 20 Jun 1995 Cleared FDA 510(k) K952179
2. 20 Sep 2016 Listed FDA GUDID 05060500091057

Trade name

Synermed®

Generic name

Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

Model / Ref / Catalog

ISE720

Primary DI / UDI-DI

05060500091057

510(k) Number

K952179 ↗

FDA product code

CEM, CGZ, JGS

GMDN term

Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

Device class

Class II

Regulation number

862.1600, 862.1170, 862.1665

GUDID distribution status

In Commercial Distribution

Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

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• Vitros Chemistry Products K+Dt Slides: Vitros Chemistry Products Dt Calibrator Kit, Model K+Dt Slides: 153 2258 by Ortho-Clinical Diagnostics
• EASTLYTE NA/K/CA/PH by Medica Corp.
• EasyStat 300 by Medica Corp.
• Amdev Lytening 2 Sodium/Potassium/Lithium/Analyzer by Baxter Healthcare Corp
• Avl Model 985 Electrolyte Analyzer by Avl Scientific Corp.
• RAPIDChem® 700 Lithium Sensor 10308981 583772 by Siemens Healthcare Diagnostics Inc.
• Vision Potassium by Abbott Laboratories

• Synermed® VI135-L

  Class II

  FDA 510(k) K903511 Active Cleared 7 Sep 1990 GUDID on market

• Synermed® IR-500

  Class I

  FDA 510(k) K935662 Active Cleared 26 Apr 1994 GUDID on market

• Synermed® IR462-L

  Class I

  FDA 510(k) K923414 Active Cleared 22 Sep 1992 GUDID on market

• Synermed® VI411-L

  Class I

  FDA 510(k) K931958 Active Cleared 8 Sep 1993 GUDID on market

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