510(k) K970227 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER
| Applicant | Dpc Cirrus, Randolph NJ, US |
| Decision | Substantially Equivalent, Apr 8, 1997 |
| Received | Jan 17, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970227
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 15, 2020 | Siemens Healthcare Diagnostics Inc. Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use in a laboratory environment only. Terminated |
JJE | None listed |
| May 15, 2020 | Siemens Healthcare Diagnostics Inc. Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a laboratory environment only. Terminated |
JJE | None listed |
| May 23, 2015 | Siemens Medical Solutions Diagnostics Water bottles, Catalog#10380062, #10291586.
The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, pl Terminated |
JJE | None listed |
| May 23, 2015 | Siemens Medical Solutions Diagnostics Accessory Kit, Catalog#10282965, #10373217,#10286080.
The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasm Terminated |
JJE | None listed |
| May 23, 2015 | Siemens Medical Solutions Diagnostics Direct Water feed Kit, Catalog#10373222 Terminated |
JJE | None listed |
| May 23, 2015 | Siemens Medical Solutions Diagnostics Water Feed Kit, Catalog#10288216,#10389714.
The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urin Terminated |
JJE | None listed |
| May 23, 2015 | Siemens Medical Solutions Diagnostics Liquid Waste Bottle Kit, Catalog#10386287.
The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, pla Terminated |
JJE | None listed |
| Jun 19, 2014 | Siemens Medical Solutions Diagnostics VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user interface that routes samples, reduces manual Terminated |
LXG | None listed |
| Apr 2, 2014 | Siemens Medical Solutions Diagnostics IMMULITE 2000; IMMULITE 2000XPi; VersaCell
The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine Terminated |
JJE | None listed |
| Jun 24, 2010 | Siemens Healthcare Diagnostics Inc. IMMULITE 2000/2500 Chemiluminescent Substrate Module
For the use in the routine operation of the IMMULITE 2000 and IMMULITE 2500 Analyzer. Terminated |
JJE | None listed |
| Mar 10, 2010 | Siemens Healthcare Diagnostics Inc. IMMULITE 2000 and IMMULITE 2500
IgG/IgM Sample Diluent, Cat. No. L2IGZ2, Lot Number 150 Terminated |
LFX | None listed |
| May 26, 2009 | Siemens Medical Solutions Diagnostics Immulite 2000 and Immulite 2500 digital Fluidics PC Board,
Part Number 450116-0002.
Performs chemiluminescent immunoassays using serum, plasma, and/or urine for in vitro diagnostic testing. Terminated |
DGC | None listed |
| Jul 16, 2005 | DPC Cirrus IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic Use. Manufactured by DPC Cirrus Inc., Flanders, NJ 07836 Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.