510(k) K011342 ยท GKZ Counter, Differential Cell
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
| Applicant | Beckman Coulter, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Jul 9, 2001 |
| Received | May 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011342
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2017 | Beckman Coulter Inc. Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers
Hematology Analyzers are quantitative, automated hematology analyzers and leukocyte differential counters For In Vitro Diagnostic used in Terminated |
GKZ | None listed |
| 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 750 Hematology Analyzer, Part No. 6605632,
A85570
Product Usage:
The Coulter LH 750 Hematology Analyzer 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 750 Analyzer,
part number: LH750 System Help 2D1.103272,
PN 6605632, PN 6605632R & PN A85570.
SW Version 2D1, 2D2.
Serial Number: all.
The COULTER LH 750 Hematology Analyzer is a quant Terminated |
GKZ | None listed |
| Apr 12, 2011 | Beckman Coulter Inc. Coulter LH750 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 LH750 Analyzer, Part Number 6605632, Beckman Coulter, Brea, CA. (Beckman Coulter, Brea, CA. (Hematology analyzer) Terminated |
GKZ | None listed |
| Mar 6, 2007 | Beckman Coulter Inc Coulter LH700 Series Hematology Analyzers, Part Number 6605632 with 2B Software (2B3, 2B4 and 2B5) Terminated |
GKZ | None listed |
| Feb 4, 2006 | Beckman Coulter Inc COULTER LH 700 Series Hematology Analyzer, PN
6605632 and 6605632R Terminated |
GKZ | None listed |
| Jul 20, 2004 | Beckman Coulter Inc Coulter LH750 Hematology Analyzer. Part Number 6605632. Terminated |
GKZ | None listed |
| Mar 21, 2003 | Beckman Coulter Inc LH 700 Series Hematology Analyzers.
Part numbers 66056032, 6605633, 6605645 Terminated |
GKZ | None listed |
| Feb 25, 2003 | Beckman Coulter Inc Coulter LH 700 Series and GEN S Hematology Analyzers
864.5220 Automated differential cell counter Terminated |
None listed | |
| Feb 5, 2003 | Beckman Coulter Inc Coulter LH 700 Series Hematology Analyzers Terminated |
GKZ | None listed |
| Jan 9, 2003 | Beckman Coulter Inc COULTER LH 700 Series Hematology Analyzers Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.