FDA Product Code
FDA Product Code CGZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1170
510(k) Clearances — 38 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K182072 | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides | Ortho-Clinical Diagnostics, Inc. | 2018-10-30 | Traditional | PDF ↗ |
| K170320 | Alinity c ICT Sample Diluent | Abbott Laboratories | 2017-10-24 | Traditional | PDF ↗ |
| K162020 | VITROS Chemistry Products Cl- Slides | Ortho Clinical Diagnostics | 2016-12-16 | Traditional | PDF ↗ |
| K082099 | VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905 | Ortho-Clinical Diagnostics, Inc. | 2008-08-21 | Special | PDF ↗ |
| K070889 | AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 | Wallac OY | 2008-04-14 | Traditional | PDF ↗ |
| K070531 | ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER | Thermo Fisher Scientific | 2007-09-04 | Traditional | PDF ↗ |
| K060108 | COBAS INTEGRA CHLORIDE ELCTRODE GEN.2 | Roche Diagnostics Corp. | 2006-02-16 | Special | PDF ↗ |
| K052027 | OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 | Osmetech, Inc. | 2005-09-29 | Traditional | PDF ↗ |
| K020148 | pHoenix ISE Reagents FOR Olympus AU Chemistry Systems | Phoenix Diagnostics, Inc. | 2002-02-04 | Traditional | PDF ↗ |
| K013451 | PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES | Phoenix Diagnostics, Inc. | 2001-12-18 | Traditional | PDF ↗ |
| K003664 | DELFIA NEONATAL IRT KIT, MODEL A005-110 | Wallac OY | 2001-02-14 | Traditional | PDF ↗ |
| K003668 | AUTODELFIA NEONATAL IRT KIT, MODEL B005-112 | Wallac OY | 2001-02-12 | Traditional | PDF ↗ |
| K993697 | DELFIA NEONATAL IRT KIT | Wallac OY | 2000-06-09 | Traditional | PDF ↗ |
| K000926 | EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER | Medica Corp. | 2000-05-15 | Traditional | PDF ↗ |
| K991870 | ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03 | A.P. Total Care, Inc. | 1999-07-30 | Traditional | PDF ↗ |
| K981270 | IRMA BLOOD ANALYSIS SYSTEM | Diametrics Medical, Inc. | 1998-05-01 | Traditional | PDF ↗ |
| K980757 | ILAB 600 CLINICAL CHEMISTRY SYSTEM | Instrumentation Laboratory CO | 1998-04-21 | Traditional | PDF ↗ |
| K980367 | AEROSET SYSTEM | Abbott Laboratories | 1998-04-01 | Traditional | PDF ↗ |
| K973742 | SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM | Sendx Medical, Inc. | 1997-12-03 | Traditional | PDF ↗ |
| K972004 | ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS | Alko Diagnostic Corp. | 1997-06-16 | Traditional | PDF ↗ |
| K962479 | SYNERMED ISE REAGENTS | Synermed, Inc. | 1997-03-03 | Traditional | PDF ↗ |
| K963992 | CAPILLARY ADAPTOR ACCESSORY | Medica Corp. | 1996-11-29 | Traditional | PDF ↗ |
| K963734 | ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS | Alko Diagnostic Corp. | 1996-10-24 | Traditional | PDF ↗ |
| K953861 | HICHEM ISE INTDERNAL REFERENCE KIT 70009 | Hichem Diagnostics | 1995-09-06 | Traditional | PDF ↗ |
| K953862 | HICHEM ISEKCI SOLUTION KIT 70010 | Hichem Diagnostics | 1995-09-06 | Traditional | PDF ↗ |
| K953860 | HICHEM ISE DILUENT KIT 70008 | Hichem Diagnostics | 1995-09-06 | Traditional | PDF ↗ |
| K935228 | MODEL 644 SWEAT DILUENT | Ciba Corning Diagnostics Corp. | 1994-08-01 | Traditional | PDF ↗ |
| K924864 | NOVA 13 ANALYZER, MODIFICATION | Nova Biomedical Corp. | 1992-11-06 | Traditional | PDF ↗ |
| K912561 | NOVA 13 ANALYZER | Nova Biomedical Corp. | 1991-09-11 | Traditional | PDF ↗ |
| K912647 | ISE/CI- | Boehringer Mannheim Corp. | 1991-07-17 | Traditional | PDF ↗ |
| K900887 | ABBOTT SPECTRUM AUTOMATED CLINICAL CHEM. ANALYZER | Abbott Laboratories | 1990-05-15 | Traditional | PDF ↗ |
| K893628 | OLYMPUS ISE MODULE FOR AU5000 | Olympus Corp. | 1989-08-11 | Traditional | PDF ↗ |
| K885193 | OLYMPUS ISE MODULE | Olympus Corp. | 1989-02-03 | Traditional | PDF ↗ |
| K863395 | WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER | Wescor, Inc. | 1988-05-24 | Traditional | PDF ↗ |
| K861669 | SODIUM, POTASSIUM AND CHLORIDE PROCEDURE | Data Medical Associates, Inc. | 1986-05-27 | Traditional | PDF ↗ |
| K860668 | ION-SPECIFIC ELECTRODE, CHLORIDE | Em Diagnostic Systems, Inc. | 1986-04-07 | Traditional | PDF ↗ |
| K844021 | ISE REAGENTS FOR DEMAND ANALYZER | Advanced Biomedical Methods, Inc. | 1984-12-10 | Traditional | PDF ↗ |
| K790653 | NOVA 3 CHLORIDE/TOTAL DIOXIDE ANALYZER | Nova Corp. | 1979-06-15 | Traditional | PDF ↗ |
Product code CGZ · Class II · Clinical Chemistry. Data: openFDA.