Cleared Traditional

UA-Cellular Complete

K170091 · Streck · Chemistry
Feb 2017
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K170091 is an FDA 510(k) clearance for the UA-Cellular Complete, a Urinalysis Controls (assayed And Unassayed) (Class I — General Controls, product code JJW), submitted by Streck (La Vista, US). The FDA issued a Cleared decision on February 9, 2017, 30 days after receiving the submission on January 10, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K170091 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 2017
Decision Date February 09, 2017
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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