510(k) K980367 ยท CGZ Electrode, Ion-Specific, Chloride
AEROSET SYSTEM
| Applicant | Abbott Laboratories, Irving TX, US |
| Decision | Substantially Equivalent, Apr 1, 1998 |
| Received | Jan 29, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980367
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2019 | Abbott Laboratories, Inc ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The mixer is a c Terminated |
JJE | None listed |
| 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 | None listed |
| Jul 17, 2018 | Abbott Laboratories, Inc Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are Terminated |
JJE | None listed |
| Jul 17, 2018 | Abbott Laboratories, Inc Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are Terminated |
JJE | None listed |
| Jul 17, 2018 | Abbott Laboratories, Inc Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are Terminated |
JJE | None listed |
| Jan 18, 2018 | Abbott Laboratories, Inc ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system. There are 9 segments with each cuvette segment holding 11 cuvettes for a total of 99 cuv Terminated |
JJE | None listed |
| Jan 18, 2018 | Abbott Laboratories, Inc ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT Clinical Chemistry system. There are 11 segments with each cuvette segment holding 15 cuvettes for a total of 165 c Terminated |
JJE | None listed |
| Jan 18, 2018 | Abbott Laboratories, Inc ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT Clinical Chemistry system. There are 15 segments with each cuvette segment holding 11 cuvette pairs (22 cuvettes) Terminated |
JJE | None listed |
| Sep 29, 2017 | Abbott Laboratories, Inc ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems. Completed |
JJE | None listed |
| Sep 29, 2017 | Abbott Laboratories, Inc Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems. Completed |
JJE | None listed |
| Sep 9, 2015 | Abbott Laboratories, Inc ARCHITECT i2000SR System
The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system is designed to perform automated immunoassay tests, utilizing CMIA (chemilumine Terminated |
JJE | None listed |
| Jul 22, 2015 | Abbott Laboratories ARCHITECT c8000 System List Number 01G06-98
Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is designed to perform automated: chemistry tests, utilizing Terminated |
JJE | None listed |
| Jun 27, 2015 | Abbott Laboratories ICT Serum Calibrator REF 146-03.
For use in the calibration of the serum Sodium, Potassium, and Chloride assays. Terminated |
CEM | None listed |
| Jun 8, 2015 | Abbott Laboratories Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500 mL bottles and contains NaOCl, NaOH, and KOH. It is shipped and stored at room tem Terminated |
JJE | None listed |
| Jan 15, 2015 | Abbott Laboratories, Inc ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.
Cuvette segments are a component to the ARCHITECT c4000 system. Cuvette Terminated |
JJE | None listed |
| 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 | None listed |
| May 24, 2008 | Abbott Laboratories, Inc Clinical Chemistry ICT Calibrator, List Number: 1E46-02, Abbott Labs, Abbott Park, IL 60064 Terminated |
CGZ | None listed |
| Nov 7, 2007 | Abbott Laboratories, Inc ARCHITECT c8000 Processing Module, for In Vitro Diagnostics; List Number 106-01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60, v3.00 and v3.10; Distributed by Abbott Laboratori Terminated |
JJE | None listed |
| Jun 19, 2007 | Abbott Laboratories, Inc ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60 and v3.00; distributed by Abbott Laboratories, Ir Terminated |
JJE | None listed |
| Jan 18, 2006 | Abbott Laboratories, Inc ARCHITECT c8000 System Software, Version 2.11, Product List/Model #5F48-12, distributed by Abbot Laboratories, Irving, TX. Terminated |
JJE | None listed |
| Oct 6, 2005 | Abbott Laboratories, Inc ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00. Terminated |
JJE | None listed |
| Oct 6, 2005 | Abbott Laboratories, Inc ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) f Terminated |
JJE | None listed |
| Oct 9, 2004 | Abbott Laboratories, Inc AEROSET Analyzer, Systems Operation Manual. Terminated |
JJE | None listed |
| 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 | None listed |
| Jul 20, 2004 | Abbott Laboratories, Inc AEROSET System Software version 1.02ER000 Terminated |
JQP | None listed |
| Jul 20, 2004 | Abbott Laboratories, Inc ARCHTECT System RS-232 Manual, product list number 06F71-04, for the ARCHITECT i2000 Processing Module and the ARCHITECT c8000 Processing Module. The product is manufactured and distributed by Abbott Terminated |
JJE | None listed |
| Jul 20, 2004 | Abbott Laboratories, Inc AEROSET Analyzer System, Model 9D05-01, distributed by Abbott Laboratories Diagnostic Division, Irving, Texas Terminated |
JJE | None listed |
| Dec 24, 2003 | Abbott Laboratories, Inc The ARCHITECT c8000, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas Terminated |
JQP | None listed |
| Aug 21, 2003 | Abbott Laboratories, Inc Abbott Aeroset System list number 9D05-01, manufactured by Abbott Diagnostic Division, Irving, Texas Terminated |
JJE | None listed |
| May 20, 2003 | Abbott Laboratories, Inc Aeroset Analyzer, item 9D05-01 Terminated |
JJE | None listed |
| May 20, 2003 | Abbott Laboratories, Inc AEROSET Analyzer Terminated |
JJE | None listed |
| May 9, 2003 | Abbott Laboratories, Inc AEROSET System External Waste Pump Terminated |
JJE | None listed |
| May 1, 2003 | Abbott Laboratories, Inc AEROSET ICT Module, Reagent module for sodium, potassium, and chloride. List number 9D05-01. Terminated |
JJE | None listed |
| Apr 16, 2003 | Abbott Laboratories, Inc AEROSET Software versions 1.00ER005, catalog number 2-89996-01 and 1.00ER005.2, catalog number 2-89996-02 Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.