Cleared Abbreviated

LIPOPROTEIN FOR MULTIPLE ANALYTES

K051619 · Bayer Healthcare, LLC · Chemistry
Aug 2005
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K051619 is an FDA 510(k) clearance for the LIPOPROTEIN FOR MULTIPLE ANALYTES, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Bayer Healthcare, LLC (New York, US). The FDA issued a Cleared decision on August 1, 2005, 45 days after receiving the submission on June 17, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K051619 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 2005
Decision Date August 01, 2005
Days to Decision 45 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIX — Calibrator, Multi-analyte Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

Similar Devices — JIX Calibrator, Multi-analyte Mixture

All 301
VITROS Chemistry Products Calibrator Kit 3
K161140 · Ortho-Clinical Diagnostics, Inc. · May 2016
ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator
K153365 · Siemens Healthcare Diagnostics, Inc. · Dec 2015
ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II
K151552 · Elitechgroup · Jul 2015
Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
K140790 · Siemens Healthcare Diagnostics · Jun 2015
SYSTEM CALIBRATER
K141388 · Beckman Coulter Ireland, Inc. · Jul 2014
C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN
K133330 · Roche Diagnostics · Nov 2013