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Synermed® ISE710

by Infrared Laboratory Systems LLC

Synermed® ISE710 is a Class II device made by Infrared Laboratory Systems LLC, cleared under FDA 510(k) K952179 on 20 Jun 1995 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 05060500091040), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K952179

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05060500091040 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK952179 Date20 Jun 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K952179 decided 20 Jun 1995 Active
  • FDA GUDID UDI-DI 05060500091040 listed 20 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K952179
  2. Listed FDA GUDID 05060500091040

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Synermed®
Generic name
Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
Model / Ref / Catalog
ISE710
Primary DI / UDI-DI
05060500091040
510(k) Number
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

Related devices

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

Cleared under the same submission (K952179)

Similar devices

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

Other devices from Infrared Laboratory Systems LLC

  • Synermed® VI135-L

    Class II

  • Synermed® IR-500

    Class I

  • Synermed® ISE720

    Class II

  • Synermed® IR462-L

    Class I

See all devices from Infrared Laboratory Systems LLC →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)