Panels › Hematology › Product code GGK · Class 1
Products, Red-Cell Lysing Products
Regulation 864.8540
0510(k)s in 12 months (29 all time)
0recalls in 12 months (7 all time)
1recalls that name a 510(k)
Top companies in GGK
| Company | 510(k)s | Recalls |
|---|---|---|
| E K Ind., Inc. | 4 | 0 |
| Beckman Coulter Inc. | 0 | 3 |
| Connecticut Diagnostics, Ltd. | 2 | 0 |
| Hematology Marketing Assoc. | 2 | 0 |
| Reagent Laboratory, Inc. | 2 | 0 |
| Sysmex America, Inc. | 0 | 2 |
| Abbott Diagnostics | 1 | 0 |
| Abbott Laboratories | 0 | 1 |
| Central Labs. Assoc. MD Pathologists | 1 | 0 |
| Coulter Immunology | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office BECKMAN COULTER, INC.
a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULTR, Catalog #628020.
b. COULTER DxH Cleaner REAGENT, CLEANER FP DXH 10LCOULTR Catalog #628023.
c. DxH 500 Series Lyse L Open, Classified |
GGK | None listed |
| Sep 19, 2011 | Beckman Coulter Inc. COULTER DxH Cell Lyse, Part number 628018(1L) and 628019 (5L).
The COULTER DxH Cell Lyse is an erythrocyte lytic agent used for quantitative
determination of hemoglobin, enumeration of NRBC, and coun Terminated |
GGK | None listed |
| Aug 23, 2011 | Sysmex America, Inc. Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboa Terminated |
GGK | None listed |
| Jul 13, 2011 | Sysmex America, Inc. Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboa Terminated |
GGK | None listed |
| May 20, 2011 | Beckman Coulter Inc. COULTER Ac"T" 5diff Fix Reagent.
Part Number: 8547171
COULTER AC"T" 5diff Fix, Instructions for Use, PN 772264. Intended for use as a leukocyte reagent to differentiate subpopulations of cells on Terminated |
GGK | None listed |
| May 19, 2011 | Beckman Coulter Inc. COULTER LYSE S III diff Lytic Part Number: 8546796.
COULTER LYSE S III diff Lytic Reagent For use as an erythrocyte lytic agent for the quantitative determination of hemoglobin and for leukocyte coun Terminated |
GGK | None listed |
| May 14, 2008 | Abbott Laboratories White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell lysing reagent, List Number 01H77-01, Supplied in 3.8L bottles, Abbott Laboratories, Abbott Pa Terminated |
GGK | K051215 K961439 |
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