Cleared Traditional

MICROPROTEIN REAGENT SET

K070757 · Pointe Scientific, Inc., · Chemistry
Dec 2007
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K070757 is an FDA 510(k) clearance for the MICROPROTEIN REAGENT SET, a Lowry (colorimetric), Total Protein (Class II — Special Controls, product code JGP), submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on December 4, 2007, 259 days after receiving the submission on March 20, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K070757 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 2007
Decision Date December 04, 2007
Days to Decision 259 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JGP — Lowry (colorimetric), Total Protein
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1635