Cleared Traditional

CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM

K021428 · Bayer Corp. · Chemistry
Jul 2002
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K021428 is an FDA 510(k) clearance for the CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM, a Enzymatic Method, Creatinine (Class II — Special Controls, product code JFY), submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on July 5, 2002, 63 days after receiving the submission on May 3, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K021428 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 2002
Decision Date July 05, 2002
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFY — Enzymatic Method, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

Similar Devices — JFY Enzymatic Method, Creatinine

All 48
QSCHECK UISACR
K252619 · Qstag, Inc. · Feb 2026
Atellica CH Enzymatic Creatinine_3 (ECre3)
K212223 · Siemens Healthcare Diagnostics, Inc. · Nov 2021
Yumizen C1200 Creatinine PAP
K193649 · HORIBA ABX SAS · May 2021
ACR LAB Urine Analysis Test System
K182384 · Healthy.Io, Ltd. · Jul 2019
GEM Premier ChemSTAT
K183555 · Instrumentation Laboratory CO · Feb 2019
URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
K182038 · Yd Diagnostics Corporation · Dec 2018