Home / 510(k) Clearances / K981270

510(k) K981270

IRMA BLOOD ANALYSIS SYSTEM by Diametrics Medical, Inc. — Product Code CGZ

K981270 is an FDA 510(k) premarket notification submitted by Diametrics Medical, Inc. for the device "IRMA BLOOD ANALYSIS SYSTEM". The FDA issued a decision of Substantially Equivalent on May 1, 1998. The device falls under product code CGZ (Electrode, Ion-Specific, Chloride), a Class II device regulated under 21 CFR 862.1170. Diametrics Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1998
Date Received
April 7, 1998
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 Diametrics Medical, Inc.

  • K030035 — IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE (June 25, 2003)
  • K013938 — IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE (January 28, 2002)
  • K011586 — IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE (November 16, 2001)
  • K983198 — TRENDCARE CALIBRATOR MODEL SCU 7007 (November 23, 1999)
  • K980380 — NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARA (July 14, 1999)
  • K980523 — IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE (March 19, 1998)
  • K972314 — PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIO (December 19, 1997)
  • K974396 — IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MOD (December 18, 1997)
  • K970906 — PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 (September 23, 1997)
  • K945240 — IRMA BLOOD ANALYSIS SYSTEM (January 5, 1995)

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