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510(k) K962479

SYNERMED ISE REAGENTS by Synermed, Inc. — Product Code CGZ

K962479 is an FDA 510(k) premarket notification submitted by Synermed, Inc. for the device "SYNERMED ISE REAGENTS". The FDA issued a decision of Substantially Equivalent on March 3, 1997. The device falls under product code CGZ (Electrode, Ion-Specific, Chloride), a Class II device regulated under 21 CFR 862.1170. Synermed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1997
Date Received
June 26, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion-Specific, Chloride
Device Class
Class II
Regulation Number
862.1170
Review Panel
CH
Submission Type

Other clearances by Synermed, Inc.

  • K973109 — SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT (September 25, 1997)
  • K972716 — SYNERMED TOTAL BILIRUBIN REAGENT KIT (August 7, 1997)
  • K971491 — SYNERMED IR 200 CHEMISTRY ANALYZER (June 26, 1997)
  • K963939 — SYNERMED DIRECT BILIRUBIN REAGENT KIT (December 18, 1996)
  • K960793 — SYNERMED ENZYMATIC CO2 REAGENT KIT (March 11, 1996)
  • K953395 — SYNERMED CALCIUM REAGENT KIT (August 31, 1995)
  • K952179 — SYNERMED ISE REAGENTS (June 20, 1995)
  • K943924 — CREATININE-PO REAGENT KIT (September 20, 1994)
  • K941091 — SYNERMED AMYLASE REAGENT KIT (May 3, 1994)
  • K935662 — SYNERMED IR 500 CHEMISTRY ANALYZER (April 26, 1994)

Other clearances for product code CGZ

  • K182072 — VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITR (October 30, 2018)
  • K170320 — Alinity c ICT Sample Diluent (October 24, 2017)
  • K162020 — VITROS Chemistry Products Cl- Slides (December 16, 2016)
  • K082099 — VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR (August 21, 2008)
  • K070889 — AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 (April 14, 2008)
  • K070531 — ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALY (September 4, 2007)
  • K060108 — COBAS INTEGRA CHLORIDE ELCTRODE GEN.2 (February 16, 2006)
  • K052027 — OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 (September 29, 2005)
  • K020148 — pHoenix ISE Reagents FOR Olympus AU Chemistry Systems (February 4, 2002)
  • K013451 — PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES (December 18, 2001)

FDA data resources