510(k) K061616 ยท GKZ Counter, Differential Cell
COULTER LH 780 HEMATOLOGY ANALYZER
| Applicant | Beckman Coulter, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Oct 4, 2006 |
| Received | Jun 8, 2006 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K061616
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 28, 2015 | Beckman Coulter Inc. COULTER LH Series Diluent, Catalog No. 8547194, Product Labeling A40192-AD. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as re Terminated |
GIF | None listed |
| Aug 28, 2015 | Beckman Coulter Inc. COULTER ISOTON 4 Diluent, Catalog No. 8547148. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets. Terminated |
GIF | None listed |
| Dec 10, 2013 | Beckman Coulter Inc. Coulter LH 780 Hematology Analyzer, Part No. 723585,
A90728
Product Usage:
Coulter LH 780 Hematology Analyzer is a is a quantitative, automated hematology analyzer and leukocyte differential counter Terminated |
GKZ | None listed |
| Nov 1, 2013 | Beckman Coulter Inc. COULTER LH 750
and LH 780 Analyzers.
The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical Terminated |
GKZ | None listed |
| Mar 21, 2012 | Beckman Coulter Inc. COULTER LH 780 Analyzer,
part number: LH780 System Help 1B1.103272,
PN 723585.
SW Version: 1B1, 1B2.
Serial Number: all.
The COULTER LH 780 Hematology Analyzer is a quantitative, automated hemat Terminated |
GKZ | None listed |
| Apr 12, 2011 | Beckman Coulter Inc. Coulter LH780 Analyzer
The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. Terminated |
GKZ | None listed |
| Dec 22, 2007 | Beckman Coulter Inc COULTER LH780 Analyzer , Part Number: 723585, Beckman Coulter, Brea, CA. (Hematology analyzer) Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.