Cleared Traditional

AMPHETAMINES II ASSAY

K093664 · Roche Diagnostics Corp. · Chemistry
Jul 2010
Decision
243d
Days
Class 2
Risk

About This 510(k) Submission

K093664 is an FDA 510(k) clearance for the AMPHETAMINES II ASSAY, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on July 28, 2010, 243 days after receiving the submission on November 27, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K093664 FDA.gov
FDA Decision Cleared SESE
Date Received November 27, 2009
Decision Date July 28, 2010
Days to Decision 243 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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