Cleared Special

ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U.

K001225 · Princeton BioMeditech Corp. · Toxicology
May 2000
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K001225 is an FDA 510(k) clearance for the ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U., a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on May 17, 2000, 30 days after receiving the submission on April 17, 2000. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K001225 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2000
Decision Date May 17, 2000
Days to Decision 30 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DKZ — Enzyme Immunoassay, Amphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

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