Cleared Traditional

AMPHETAMINES II

K083764 · Roche Diagnostics Corp. · Chemistry
Feb 2010
Decision
412d
Days
Class 2
Risk

About This 510(k) Submission

K083764 is an FDA 510(k) clearance for the AMPHETAMINES II, 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 February 3, 2010, 412 days after receiving the submission on December 18, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K083764 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2008
Decision Date February 03, 2010
Days to Decision 412 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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