Cleared Traditional

GenPrime Snap-Top Split Key Cup

K140665 · Genprime, Inc. · Toxicology
Dec 2014
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K140665 is an FDA 510(k) clearance for the GenPrime Snap-Top Split Key Cup, a Enzyme Immunoassay, Barbiturate (Class II — Special Controls, product code DIS), submitted by Genprime, Inc. (Spokane, US). The FDA issued a Cleared decision on December 8, 2014, 265 days after receiving the submission on March 18, 2014. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3150.

Submission Details

510(k) Number K140665 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2014
Decision Date December 08, 2014
Days to Decision 265 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIS — Enzyme Immunoassay, Barbiturate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3150

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