Cleared Traditional

LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS

K102210 · Lin-Zhi International, Inc. · Chemistry
Dec 2010
Decision
145d
Days
Class 2
Risk

About This 510(k) Submission

K102210 is an FDA 510(k) clearance for the LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Lin-Zhi International, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 28, 2010, 145 days after receiving the submission on August 5, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K102210 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2010
Decision Date December 28, 2010
Days to Decision 145 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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