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Panels › Clinical Toxicology › Product code LFG · Class 2

Radioimmunoassay, Tricyclic Antidepressant Drugs

Regulation 862.3910

0510(k)s in 12 months (21 all time)
1recalls in 12 months (2 all time)
2recalls that name a 510(k)
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Top companies in LFG

Company510(k)sRecalls
Syva Co.90
Guangzhou Wondfo Biotech Co., Ltd.20
Ucp Biosciences, Inc.20
Wien Laboratories, Inc.20
Abbott Health Products, Inc.01
Abbott Laboratories10
ACON Laboratories, Inc.10
E.I. Dupont DE Nemours & Co., Inc.10
Healgen Scientific,, LLC10
Medtox Diagnostics, Inc.10
DateFirm and productCodeLinked 510(k)
Aug 4, 2026Siemens Healthcare Diagnostics, Inc.
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
Open, Classified		 LFGK821743
Jan 10, 2004Abbott Health Products, Inc.
TDx/TDxFLx Tricyclic Antidepressants Reagent. Distributed under the following label: TDx/TDxFLx Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064.
Terminated		 LFGK853113

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