Synermed® ISE810

• FDA 510(k) K962479 decided 3 Mar 1997 Active
• FDA GUDID UDI-DI 05060500091088 listed 20 Sep 2016 Listed

1. 3 Mar 1997 Cleared FDA 510(k) K962479
2. 20 Sep 2016 Listed FDA GUDID 05060500091088

Trade name

Synermed®

Generic name

Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

Model / Ref / Catalog

ISE810

Description

Olympus ISE Mid Standard 6 X 1000 mL

Primary DI / UDI-DI

05060500091088

510(k) Number

K962479 ↗

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).

• CIBA CORNING 300 SERIES SYSTEM by Ciba Corning Diagnostics Corp.
• STARLYTE by Electro-Nucleonics Laboratories, Inc.
• VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927 by Ortho-Clinical Diagnostics
• Dimension® QuikLYTE® Multisensor Na+/K+/Cl- 10445058 S600 by Siemens Healthcare Diagnostics Inc.
• EPOC BLOOD ANALYSIS SYSTEM by Epocal Inc
• EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER by Medica Corp.
• REAGENTS SERUM SODIUM USING THE TECH. by Panmed, Inc.
• Synermed ISE Reagents by Infrared Laboratory Systems dba SYNERMED
• ARCHITECT 2P32-11 02P3211 by Abbott Laboratories
• Cleaning Solution with additive S8375 REF 944-126 by Radiometer Medical ApS

• 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

See all devices from Infrared Laboratory Systems LLC →