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510(k) K973742

SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM by Sendx Medical, Inc. — Product Code CGZ

K973742 is an FDA 510(k) premarket notification submitted by Sendx Medical, Inc. for the device "SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM". The FDA issued a decision of Substantially Equivalent on December 3, 1997. The device falls under product code CGZ (Electrode, Ion-Specific, Chloride), a Class II device regulated under 21 CFR 862.1170. Sendx Medical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1997
Date Received
October 1, 1997
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 Sendx Medical, Inc.

  • K151639 — ABL80 FLEX and ABL80 FLEX CO-OX (December 7, 2015)
  • K151856 — ABL80 FLEX CO-OX with AQURE connectivity (August 6, 2015)
  • K080370 — ABL 80 CO-OX SYSTEM (July 31, 2008)
  • K051804 — ABL80 FLEX ANALYZER (November 1, 2005)
  • K994346 — ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM (February 1, 2000)

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