510(k) K981801

ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA by Princeton BioMeditech Corp. — Product Code LFH

K981801 is an FDA 510(k) premarket notification submitted by Princeton BioMeditech Corp. for the device "ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA". The FDA issued a decision of Substantially Equivalent on August 25, 1998. The device falls under product code LFH (U.V. Spectrometry, Tricyclic Antidepressant Drugs), a Class II device regulated under 21 CFR 862.3910. Princeton BioMeditech Corp. has at least 10 other 510(k) clearances on record.