Panels › Hematology › Product code GIF · Class 1
Diluent, Blood Cell
Regulation 864.8200
0510(k)s in 12 months (38 all time)
1recalls in 12 months (13 all time)
8recalls that name a 510(k)
Top companies in GIF
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2026 | Beckman Coulter, Inc. COULTER DxH Diluent, REF 628017
COULTER DxH ECO Diluent REF C67250
For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all Un Open, Classified |
GIF | None listed |
| Jul 12, 2023 | Beckman Coulter, Inc. COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells Open, Classified |
GIF | None listed |
| Jan 24, 2018 | Mindray DS USA, Inc. dba Mindray North America Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L container)
The M-53D diluent is an azide-free, filtered isotonic solution for counting and sizing blood Terminated |
GIF | None listed |
| Jan 24, 2018 | Mindray DS USA, Inc. dba Mindray North America Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; Part Numbers: (1) 105-005405-00 (2 x 5.5L container), (2) 105-005406-00 (20L container)
The M-30D Diluent is an azide-free 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 | K011342 K061616 |
| 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 | K011342 K061616 |
| May 15, 2015 | Beckman Coulter Inc. COULTER DxH Diluent, Catalog No. 628017, Part No. A59956.
For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells. Terminated |
GIF | K081930 K120771 |
| Sep 16, 2014 | Beckman Coulter Inc. Coulter DxH Diluent, Catalog No. 628017
Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a diluent. The diluent provides the ability to analyze portions o Terminated |
GIF | None listed |
| Apr 3, 2007 | Abbott Laboratories CELL-DYN Sapphire and CELL-DYN 4000 Diluent/Sheath Systems- List No. 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA Terminated |
GIF | K051215 K961439 |
| Apr 3, 2007 | Abbott Laboratories CELL-DYN 3200 Diluent/Sheath Reagent,
List Number 03H79-01,Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA Terminated |
GIF | K972354 |
| Mar 17, 2007 | Abbott Laboratories CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured by:
Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA Terminated |
GIF | K961439 |
| Mar 16, 2007 | Abbott Laboratories CELL-DYN 4000 Diluent/Sheath Reagent,
List Number 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA Terminated |
GIF | K961439 |
| Mar 1, 2007 | Abbott Laboratories CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. List #01H73-01. Packaged in 20 Liter cubitainers. Terminated |
GIF | K051215 K061667 +1 |
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