Cleared Traditional

URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II

K881275 · Fisher Scientific Co., LLC · Chemistry
May 1988
Decision
52d
Days
Class 1
Risk

About This 510(k) Submission

K881275 is an FDA 510(k) clearance for the URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Fisher Scientific Co., LLC (Orangeburg, US). The FDA issued a Cleared decision on May 16, 1988, 52 days after receiving the submission on March 25, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K881275 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 1988
Decision Date May 16, 1988
Days to Decision 52 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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