ClearanceBrief
Panels › Clinical Chemistry › Product code JIS · Class 2

Calibrator, Primary

Regulation 862.1150

0510(k)s in 12 months (130 all time)
0recalls in 12 months (21 all time)
15recalls that name a 510(k)
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Top companies in JIS

DateFirm and productCodeLinked 510(k)
May 27, 2025Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
Open, Classified
JISK013406
May 27, 2025Siemens Healthcare Diagnostics, Inc.
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Open, Classified
JISNone listed
May 14, 2024QUIDELORTHO
VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or hepari
Open, Classified
JISK994145
Mar 8, 2022Abbott Laboratories
ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitativ
Open, Classified
JISK042924
Jul 29, 2021Sentinel CH SpA
Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], o
Terminated
JISNone listed
Dec 22, 2020Fujifilm Medical Systems U.S.A., Inc.
Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determination of high density lipoprotein cholesterol (HDL-C) or low density lipoprotein
Terminated
JISK001005
Nov 29, 2018Ortho Clinical Diagnostics Inc
Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated Sy
Terminated
JISK033300
Mar 15, 2017Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c
Terminated
JISK103836
Oct 24, 2016Beckman Coulter Inc.
Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline
Terminated
JISK994278
Aug 14, 2013Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). For calibrating the following assays using the ADVIA Centaur or ACS:180 systems: FT3
Terminated
JISK961510
Apr 15, 2013Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For use in the quantitative determination of Vit D.
Terminated
JISNone listed
Apr 15, 2013Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For use in the quantitative determination of Vit D.
Terminated
JISNone listed
Jan 29, 2013Siemens Healthcare Diagnostics, Inc.
Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the Iron method for the Dime
Terminated
JISK060266
Dec 22, 2012Beckman Coulter Inc.
Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total t
Terminated
JISK023369
Jun 21, 2011Beckman Coulter Inc.
Access Immunoassay Systems Ostase Calibrators, Part Number: 37305 The Access Ostase Calibrators are used to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosp
Terminated
JISK994278
Jul 24, 2008Abbott Diagnostic International, Ltd.
AxSYM Ultrasensitive hTSH II Master Calibrators Microparticle Enzyme Immunoassay that determines amount of human thyroid stimulating hormone in human serum and plasma.
Terminated
JISK952148
Oct 28, 2006Tosoh Bioscience Inc
TOSOH AIA-PACK FOLATE Calibrator Sets, six levels, Catalog Number-020392. The calibrators are packaged in 1 ml glass vials with 12 glass vials per box.
Terminated
JISK992365
Oct 12, 2006Abbott Diagnostic International, Ltd.
Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.
Terminated
JISK935612
Jul 23, 2004Beckman Coulter Inc
Synchron Systems Lipid Calibrator (HDLD) Part 650218
Terminated
JISK983640
Jul 23, 2004Beckman Coulter Inc
Synchron Systems Prealbumin Reagent Part Number: 475106
Terminated
JISNone listed
Jul 20, 2004Beckman Coulter Inc
Synchron CX (and) Synchron LX Systems Microalbumin Calibrator.
Terminated
JISNone listed

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