510(k) K032000 ยท GKZ Counter, Differential Cell
COULTER LH 500 HEMATOLOGY ANALYZER
| Applicant | Beckman Coulter, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Aug 13, 2003 |
| Received | Jun 10, 2003 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K032000
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2012 | Beckman Coulter Inc. COULTER LH 500 Series System ,
part number: LH500 System Help 2A4.103271;
LH 500 Series System 100V, PN 178832;
LH 500 Series System 120V, PN 178833;
LH 500 Series System 240V, PN 178834; Terminated |
GKZ | None listed |
| Jan 11, 2012 | Beckman Coulter Inc. Coulter LH500 Series Analyzer,
Part number: 178832, 178833, 178834.
LH 500 Series System Instructions for Use, PN 624602 Rev BA. The COULTER LH 500 Analyzer is a quantitative, automated hematology a Terminated |
GKZ | None listed |
| Apr 20, 2011 | Beckman Coulter Inc. COULTER LH 500 Series Analyzer
Part number: 178832, 178833, 178834
The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter For In Vitro D Terminated |
GKZ | None listed |
| Apr 12, 2011 | Beckman Coulter Inc. Coulter LH500 Series System
The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories. Terminated |
GKZ | None listed |
| Sep 1, 2010 | Beckman Coulter Inc. COULTER LH 500 Series System Terminated |
GKZ | None listed |
| May 26, 2010 | Beckman Coulter Inc. Coulter LH 500 Series System. Beckman Coulter, Inc. Brea, CA.
Quantitative, automated hematology analyzer and leukocyte differential cell counter for in vitro diagnostic use in clinical laboratories Terminated |
GKZ | None listed |
| Dec 22, 2007 | Beckman Coulter Inc COULTER LH 500 Series System, Part Number: 178833, Beckman Coulter, Brea, CA. (Hematology analyzer) Terminated |
GKZ | None listed |
| Jul 18, 2006 | Beckman Coulter Inc Coulter LH500 Hematology Analyzer: Part Numbers 178832, 178833, 178834 Terminated |
LOQ | None listed |
| Sep 2, 2004 | Beckman Coulter Inc COULTER LH 500 Hematology Analyzer part numbers: 178832, 178833, and 178834 software versions 1A and 1A2. The LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differenti Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.