Panels › Hematology › Product code KQC · Class 1
Stains, Hematology
Regulation 864.1850
0510(k)s in 12 months (9 all time)
0recalls in 12 months (5 all time)
0recalls that name a 510(k)
Top companies in KQC
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 27, 2018 | Sysmex America, Inc. Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire, IL.
Fluorocell PLT is used to stain platelets in a diluted blood sample for the Terminated |
KQC | None listed |
| Oct 16, 2017 | Sysmex America, Inc. Sysmex Fluorocell(R) PLT
Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers Completed |
KQC | None listed |
| Sep 9, 2016 | Sysmex America Inc Fluorocell PLT reagent, Catalog #CD994563
Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers Terminated |
KQC | None listed |
| Oct 12, 2011 | EMD Chemicals Inc. Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals Inc., Gibbstown, NJ 08027 1-800-222-0342
Made in India.
The product is a Class I, IVD dye and chemical stain f Terminated |
KQC | None listed |
| Nov 3, 2007 | EMD Chemicals Inc Harleco
May and Grunwald's Stain;
0.17% w/v;
Methanol Solution UN1230;
EMD Chemicals Inc.
An Affilifate of Merck KGaA
Damstadt, Germany;
480 South Democrat Road;
Gibbstown, NJ 08027;
1 liter and 4 lit Terminated |
KQC | None listed |
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