Cleared Traditional

MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1

K890534 · Fisher Scientific Co., LLC · Chemistry
Mar 1989
Decision
41d
Days
Class 1
Risk

About This 510(k) Submission

K890534 is an FDA 510(k) clearance for the MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1, a Urinalysis Controls (assayed And Unassayed) (Class I — General Controls, product code JJW), submitted by Fisher Scientific Co., LLC (Orangeburg, US). The FDA issued a Cleared decision on March 8, 1989, 41 days after receiving the submission on January 26, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K890534 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 1989
Decision Date March 08, 1989
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJW — Urinalysis Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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