Cleared Abbreviated

ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2

K111996 · Elitechgroup · Chemistry
Sep 2011
Decision
63d
Days
Class 1
Risk

About This 510(k) Submission

K111996 is an FDA 510(k) clearance for the ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Elitechgroup (Bothell, US). The FDA issued a Cleared decision on September 14, 2011, 63 days after receiving the submission on July 13, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K111996 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 2011
Decision Date September 14, 2011
Days to Decision 63 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

Similar Devices — JJY Multi-analyte Controls, All Kinds (assayed)

All 672
Multichem IA Plus
K162530 · Techno-Path Manufacturing · Mar 2017
Audit MicroControls Linearity FD Tumor Markers II
K163629 · Aalto Scientific, Ltd. · Mar 2017
Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak
K163015 · Bio-Rad Laboratories · Jan 2017
VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
K153712 · Radiometer America, Inc. · Jan 2016
Liquichek Cardiac Markers Plus Control LT
K150300 · Bio-Rad Laboratories · Dec 2015
VALIDATE Anemia Calibration Verification/ Linearity Test Kit
K142964 · Maine Standards Company, LLC · Apr 2015

More from Elitechgroup

View all
HSV 1 & 2 ELITe MGB Kit; ELITe InGenius
K180559 · PGI · Oct 2018
ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1
K171401 · CIG · Jul 2017
ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II
K153644 · CFR · Sep 2016
ELITech Clinical Systems CALCIUM ARSENAZO
K151113 · CJY · Jul 2015
ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II
K151552 · JIX · Jul 2015