510(k) K102644 ยท GKZ Counter, Differential Cell
ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I
| Applicant | Siemens Healthcare Diagnostics, Tarrytown NY, US |
| Decision | Substantially Equivalent, Nov 23, 2011 |
| Received | Sep 14, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102644
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | None listed |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematology analyzer
-automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | None listed |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology analyzer
-automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | None listed |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | None listed |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | None listed |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | None listed |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | None listed |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | None listed |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | None listed |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | None listed |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | None listed |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | None listed |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | None listed |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | None listed |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | None listed |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | None listed |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | None listed |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | None listed |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | None listed |
| Mar 5, 2021 | Siemens Healthcare Diagnostics, Inc. ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer
Software Versions 6.10 and 6.11 Open, Classified |
GKZ | None listed |
| Oct 17, 2013 | Siemens Healthcare Diagnostics ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter)
The ADVIA 212 Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.