ClearanceBrief
Panels › Immunology › Product code DAO · Class 2

Igm (Mu Chain Specific), Antigen, Antiserum, Control

Regulation 866.5550

0510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in DAO

Company510(k)sRecalls
Advanced Cardiovascular Systems, Inc.10
Applications Lab10
Boehringer Mannheim Corp.10
Dako Corp.10
Electro-Nucleonics Laboratories, Inc.10
Helena Laboratories10
Kent Laboratories, Inc.10
Roche Diagnostics Corp.10
Decided510(k)Device and applicantCode
Mar 10, 2004K040431ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2
Roche Diagnostics Corp.
DAO
Nov 4, 1998K982639SPIFE URINE IFE
Helena Laboratories
DAO
Feb 9, 1996K955908BOEHRINGER MANNHEIM IGM ASSAY
Boehringer Mannheim Corp.
DAO
Mar 14, 1985K850586SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M
Applications Lab
DAO
Jun 11, 1984K841992MODIFICATION TO ACS CORONARY GUIDING
Advanced Cardiovascular Systems, Inc.
DAO
Sep 23, 1981K812487IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM
Dako Corp.
DAO
Apr 24, 1980K800450GEMENI IGM ASSAY
Electro-Nucleonics Laboratories, Inc.
DAO
Apr 12, 1979K790705ANTISERUM TO HUMAN IGM
Kent Laboratories, Inc.
DAO

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