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Panels › Hematology › Product code KQJ · Class 2

System, Fibrinogen Determination

Regulation 864.7340

0510(k)s in 12 months (28 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
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Top companies in KQJ

Company510(k)sRecalls
Behring Diagnostics, Inc.20
Bio/Data Corp.20
Diatech, Inc.20
Fisher Diagnostics02
Instrumentation Laboratory CO20
American Dade10
Bd Becton Dickinson Vacutainer Systems Preanalytic10
The Binding Site, Ltd.10
Crestat Diagnostics, Inc.10
Dade Behring, Inc.10
DateFirm and productCodeLinked 510(k)
Aug 28, 2025Diagnostica Stago, Inc.
STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families for the quantitative determina
Open, Classified		 KQJK840211
May 19, 2017Fisher Diagnostics
Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientif
Terminated		 KQJK800826
May 19, 2017Fisher Diagnostics
Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC
Terminated		 KQJK800826

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