Synermed® ISE730

• FDA 510(k) K952179 decided 20 Jun 1995 Active
• FDA GUDID UDI-DI 05060500091064 listed 20 Sep 2016 Listed

1. 20 Jun 1995 Cleared FDA 510(k) K952179
2. 20 Sep 2016 Listed FDA GUDID 05060500091064

Trade name

Synermed®

Generic name

Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

Model / Ref / Catalog

ISE730

Primary DI / UDI-DI

05060500091064

510(k) Number

K952179 ↗

FDA product code

JGS, CGZ, CEM

GMDN term

Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

Device class

Class II

Regulation number

862.1665, 862.1170, 862.1600

GUDID distribution status

In Commercial Distribution

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

Other devices filed under FDA product code JGS (Electrode, Ion Specific, Sodium).

• AVL #980 ELECTROLYTE ANALYZER by Gauntlet Technology Corp.
• EML105 ELECTROLYTE METABOLITE ANALYZER by RADIOMETER AMERICA, INC.
• LYTENING 1 by Amdev, Inc.
• LYTENING 2 by Amdev, Inc.
• MODEL AM 721 ELECTROLYTE ANALYZER by Abbott Diagnostics
• CORNING 614 NA/K ANALYZER by Corning Medical & Scientific
• EASYSTAT SODIUM/POTASSIUM/CHLORIDE ANALYZER by Medica Corp.
• SYNERMED ISE REAGENTS by Synermed, Inc.
• Stat Profile Prime Plus Analyzer System by NOVA BIOMEDICAL CORPORATION
• BAYER ADVIA 1650 CHEMISTRY SYSTEM by Bayer Corp.

• 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® ISE720

  Class II

  FDA 510(k) K952179 Active Cleared 20 Jun 1995 GUDID on market

• Synermed® IR462-L

  Class I

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

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