Panels › Clinical Chemistry › Product code CGZ · Class 2
Electrode, Ion-Specific, Chloride
Regulation 862.1170
0510(k)s in 12 months (38 all time)
0recalls in 12 months (11 all time)
11recalls that name a 510(k)
Top companies in CGZ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2019 | Ortho-Clinical Diagnostics VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form. Terminated |
CGZ | K071801 |
| Sep 10, 2019 | Ortho-Clinical Diagnostics VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form. Terminated |
CGZ | K071801 K162020 |
| Aug 28, 2018 | Abbott Laboratories, Inc Abbott ARCHITECT cSystems ICT Module, REF 09D28-03.
Product Usage:
The ARCHITECT cSystems ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human ser Terminated |
CGZ | K980367 |
| Jul 11, 2018 | Ortho-Clinical Diagnostics VITROS Chemistry Products Cl- Slides, Product Code 684 4471
Product Usage:
VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitati Terminated |
CGZ | K162020 |
| Jul 11, 2018 | Ortho-Clinical Diagnostics VITROS Chemistry Products Cl- Slides, Product Code 844 5207
Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration Terminated |
CGZ | K071801 |
| Jun 14, 2011 | OPTI Medical Systems, Inc OPTI LION E-Plus Cassette, Model BP7507, Opti Medical (25 Cassettes with Samples Probes per box).
Cassettes are consumables used in the OPTI LION Electrolyte Analyzer intended to be used for the mea Terminated |
CGZ | K052027 |
| Mar 11, 2010 | OPTI Medical Systems, Inc OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care.
Intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blo Terminated |
CGZ | K052027 |
| Sep 11, 2008 | Abbott Laboratories, Inc ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01 and 1G06-11, Affected software: v2.20, v2.20DB, v2.60, v3.10, 3.11 and 3.12; distributed by Abbott Laboratories, Irvin Terminated |
CGZ | K980367 |
| May 24, 2008 | Abbott Laboratories, Inc Clinical Chemistry ICT Calibrator, List Number: 1E46-02, Abbott Labs, Abbott Park, IL 60064 Terminated |
CGZ | K980367 |
| Aug 1, 2006 | Radiometer America Inc D 744 Chloride membrane, CI, REF Model #942-061, accessory to the ABL700 blood analyzer. Terminated |
CGZ | K980130 |
| Aug 13, 2004 | Abbott Laboratories, Inc ARCHITECT c8000 Processing Module; List Number 01G06-01. Manufactured by Toshiba Corporation, Medical Systems Division, Japan. Distributed by Abbott Laboratories Diagnostic Division, Irving, Texas Terminated |
CGZ | K980367 |
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