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Panels › Immunology › Product code LJM · Class 2

Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

Regulation 866.5100

0510(k)s in 12 months (112 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
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Top companies in LJM

Company510(k)sRecalls
Elias U.S.A., Inc.160
Zeus Scientific, Inc.61
American Laboratory Products Co., Ltd.60
Biohytech International, Inc.60
Theratest Laboratories, Inc.60
Lipogen, Inc.50
David A. Fuccillo, Ph.D.40
Orgentec40
Helix Diagnostics, Inc.30
Immco Diagnostics, Inc.30
DateFirm and productCodeLinked 510(k)
Mar 5, 2010Calbiotech Inc
ANA IgG ELISA 96 Well Kit, Catalog Number: AN033G The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.
Terminated		 LJMNone listed
Mar 31, 2009Zeus Scientific Inc
Sm ELISA Test System Product number 2Z2831G and Product number 43270CE Individual Enzyme-Linked Immunosorbent Assays for Antibodies to Jo-1, SM, SM/RNP, SSA, SSB and Scl-70. Manufactured by Zeus Scien
Terminated		 LJMK941409

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