Panels › Hematology › Product code GKL · Class 2
Counter, Cell, Automated (Particle Counter)
Regulation 864.5200
0510(k)s in 12 months (130 all time)
0recalls in 12 months (10 all time)
7recalls that name a 510(k)
Top companies in GKL
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2018 | Advanced Instruments, LLC GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitative determination of Terminated |
GKL | K152776 |
| Mar 18, 2016 | Becton, Dickinson and Company, BD Biosciences BD-Retic-Count Reticulocyte Reagent System;
Hematology: Used for in vitro diagnostics Terminated |
GKL | K880636 |
| Jan 20, 2015 | BD Biosciences, Systems & Reagents CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046.
Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymph Terminated |
GKL | K904390 |
| Aug 28, 2013 | Siemens Healthcare Diagnostics ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 .
The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood count Terminated |
GKL | K971998 |
| Apr 12, 2011 | Beckman Coulter Inc. Coulter GEN's
The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories. The LH500 Anal Terminated |
GKL | K962988 |
| Dec 22, 2007 | Beckman Coulter Inc COULTER GEN*S System, Part Number: 6605381, Beckman Coulter, Brea, CA. (Hematology analyzer) Terminated |
GKL | K962988 |
| Aug 4, 2006 | Bayer Healthcare, LLC (Diagnostics Division) ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter Terminated |
GKL | K971998 |
| Jul 20, 2004 | Beckman Coulter Inc Cytomics RXP Software, Version 1.0, Part Numbers:
175488
6418489
175260
175261
175262
175263
175264
175265 Terminated |
GKL | None listed |
| Jul 20, 2004 | Beckman Coulter Inc Cytomics MXP Software, Version 1.0, Part No. 623688. Terminated |
GKL | None listed |
| Jul 20, 2004 | Beckman Coulter Inc CXP software, Part No. 623560, version 1.0 Terminated |
GKL | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.