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Panels › Hematology › Product code DAP · Class 2

Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

Regulation 864.7320

1510(k)s in 12 months (58 all time)
2recalls in 12 months (13 all time)
11recalls that name a 510(k)
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Top companies in DAP

Company510(k)sRecalls
Dade Behring, Inc.64
Instrumentation Laboratory100
bioMerieux, Inc.42
Siemens Healthcare Diagnostics42
Diagnostica Stago23
Organon Teknika Corp.50
American Bioproducts Co.40
Sigma Diagnostics, Inc.40
Agen Biomedical , Ltd.30
Biosite Incorporated20
Decided510(k)Device and applicantCode
Jul 13, 1992K920943FDP PLASMA TEST KIT
American Bioproducts Co.
DAP
Jan 31, 1992K915203D-DIMER WELLCOTEST (HA10)
Wellcome Diagnostics
DAP
Jan 30, 1992K915503FIBRINOGEN FDP CONTROL
Cala Diagnostics
DAP
Oct 9, 1991K912876FIBRINOSTIKA FBDP MICROELISA SYSTEM
Organon Teknika Corp.
DAP
Mar 3, 1989K890189AGEN DIMERTEST EIA
Agen Biomedical , Ltd.
DAP
Aug 17, 1988K882944DIMERTEST(R) LATEX
Agen Biomedical , Ltd., AU
DAP
Aug 6, 1987K872195DATA-FI DIMERTEST LATEX ASSAY
American Dade
DAP
Sep 16, 1986K862156ASSERACHROM D-DI KIT
American Bioproducts Co.
DAP

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