FDA 510(k) Applications for Medical Device Product Code "LFH"
(U.V. Spectrometry, Tricyclic Antidepressant Drugs)

FDA 510(k) Number Applicant Device Name Decision Date
K983268 DIAGNOSTIC REAGENTS, INC. MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY 11/18/1998
K961393 DIAGNOSTIC REAGENTS, INC. TRICYCLICS SERUM TOX ASSAY 06/12/1996
K213875 Microgenics Corporation DRI TM Tricyclics Serum Tox Assay 12/21/2022
K981801 PRINCETON BIOMEDITECH CORP. ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA 08/25/1998


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