Cleared Traditional

UPRO

K981682 · Abbott Laboratories · Chemistry
Sep 1998
Decision
131d
Days
Class 2
Risk

About This 510(k) Submission

K981682 is an FDA 510(k) clearance for the UPRO, a Turbidimetric, Total Protein (Class II — Special Controls, product code JGQ), submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on September 21, 1998, 131 days after receiving the submission on May 13, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K981682 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 1998
Decision Date September 21, 1998
Days to Decision 131 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JGQ — Turbidimetric, Total Protein
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1635

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