Cleared Traditional

UA-CELLULAR COMPLETE

K131444 · Streck · Chemistry
Jan 2014
Decision
254d
Days
Class 1
Risk

About This 510(k) Submission

K131444 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 January 29, 2014, 254 days after receiving the submission on May 20, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K131444 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2013
Decision Date January 29, 2014
Days to Decision 254 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

Similar Devices — JJW Urinalysis Controls (assayed And Unassayed)

All 60
UA-Cellular Complete
K170091 · Streck · Feb 2017
AUTION CHECK PLUS
K142262 · Quantimetrix Corp. · Apr 2015
RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2
K110846 · Randox Laboratories Limited · Sep 2011
MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL
K103387 · ACON Laboratories, Inc. · Feb 2011
CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2
K081908 · Cliniqa Corporation · Jan 2009
IRISPEC,CA/CB/CC
K072640 · Iris Diagnostics · Dec 2007