Product code CGZ— Clinical Chemistry
ABBOTT SPECTRUM AUTOMATED CLINICAL CHEM. ANALYZER
- Classification name
- Electrode, Ion-Specific, Chloride
- Device class
- Class 2
- Regulation
- 21 CFR 862.1170
- Advisory panel
- Clinical Chemistry
- Total cleared
- 38
- First cleared
- Most recent
Market context for product code CGZ
FDA has cleared devices under product code CGZ between 1979 and 2018, filed by 25 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2018
- 2017
- 2016
- 2008
- 2007
- 2006
- 2005
- 2002
- 2001
- 2000
- 1999
- 1998
- 1997
- 1996
- 1995
Top applicants under product code CGZ
Recent clearances under product code CGZ
- K182072 — VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides
- K170320 — Alinity c ICT Sample Diluent
- K162020 — VITROS Chemistry Products Cl- Slides
- K082099 — VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905
- K070889 — AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112
- K070531 — ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER
- K060108 — COBAS INTEGRA CHLORIDE ELCTRODE GEN.2
- K052027 — OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200
- K020148 — pHoenix ISE Reagents FOR Olympus AU Chemistry Systems
- K013451 — PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES
- K003664 — DELFIA NEONATAL IRT KIT, MODEL A005-110
- K003668 — AUTODELFIA NEONATAL IRT KIT, MODEL B005-112
- K993697 — DELFIA NEONATAL IRT KIT
- K000926 — EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER
- K991870 — ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03
- K981270 — IRMA BLOOD ANALYSIS SYSTEM
- K980757 — ILAB 600 CLINICAL CHEMISTRY SYSTEM
- K980367 — AEROSET SYSTEM
- K973742 — SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
- K972004 — ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS
- K962479 — SYNERMED ISE REAGENTS
- K963992 — CAPILLARY ADAPTOR ACCESSORY
- K963734 — ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS
- K953860 — HICHEM ISE DILUENT KIT 70008
- K953861 — HICHEM ISE INTDERNAL REFERENCE KIT 70009
- K953862 — HICHEM ISEKCI SOLUTION KIT 70010
- K935228 — MODEL 644 SWEAT DILUENT
- K924864 — NOVA 13 ANALYZER, MODIFICATION
- K912561 — NOVA 13 ANALYZER
- K912647 — ISE/CI-
- K900887 — ABBOTT SPECTRUM AUTOMATED CLINICAL CHEM. ANALYZER
- K893628 — OLYMPUS ISE MODULE FOR AU5000
- K885193 — OLYMPUS ISE MODULE
- K863395 — WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER
- K861669 — SODIUM, POTASSIUM AND CHLORIDE PROCEDURE
- K860668 — ION-SPECIFIC ELECTRODE, CHLORIDE
- K844021 — ISE REAGENTS FOR DEMAND ANALYZER
- K790653 — NOVA 3 CHLORIDE/TOTAL DIOXIDE ANALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.