Cleared Traditional

SYSTEMATE PLUS CALIBRATOR

K925101 · Em Diagnostic Systems, Inc. · Chemistry
Feb 1993
Decision
138d
Days
Class 2
Risk

About This 510(k) Submission

K925101 is an FDA 510(k) clearance for the SYSTEMATE PLUS CALIBRATOR, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on February 23, 1993, 138 days after receiving the submission on October 8, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K925101 FDA.gov
FDA Decision Cleared SESE
Date Received October 08, 1992
Decision Date February 23, 1993
Days to Decision 138 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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