Cleared Traditional

POINTE 360

K062118 · Pointe Scientific, Inc., · Chemistry
Jul 2007
Decision
353d
Days
Class 2
Risk

About This 510(k) Submission

K062118 is an FDA 510(k) clearance for the POINTE 360, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on July 13, 2007, 353 days after receiving the submission on July 25, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K062118 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2006
Decision Date July 13, 2007
Days to Decision 353 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CFR — Hexokinase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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