Cleared Traditional

ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA

K981801 · Princeton BioMeditech Corp. · Toxicology
Aug 1998
Decision
96d
Days
Class 2
Risk

About This 510(k) Submission

K981801 is an FDA 510(k) clearance for the ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA, a U.v. Spectrometry, Tricyclic Antidepressant Drugs (Class II — Special Controls, product code LFH), submitted by Princeton BioMeditech Corp. (Princeton, US). The FDA issued a Cleared decision on August 25, 1998, 96 days after receiving the submission on May 21, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3910.

Submission Details

510(k) Number K981801 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 1998
Decision Date August 25, 1998
Days to Decision 96 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LFH — U.v. Spectrometry, Tricyclic Antidepressant Drugs
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3910