JIS · Class II · 21 CFR 862.1150

FDA Product Code JIS: Calibrator, Primary

Leading manufacturers include E.I. Dupont DE Nemours & Co., Inc., Beckman Coulter, Inc. and Dade Behring, Inc..

130
Total
130
Cleared
51d
Avg days
1976
Since

FDA 510(k) Cleared Calibrator, Primary Devices (Product Code JIS)

130 devices
1–24 of 130
Cleared May 31, 2006
DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR
K061251
Dade Behring, Inc.
Chemistry · 27d
Cleared Mar 09, 2006
DIMENSION IRON CALIBRATOR
K060266
Dade Behring, Inc.
Chemistry · 36d
Cleared Dec 23, 2005
DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR
K053104
Dade Behring, Inc.
Chemistry · 49d
Cleared Nov 07, 2003
DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)
K032697
Dade Behring, Inc.
Chemistry · 66d
Cleared Jun 06, 2003
CALIBRATION PLASMA LMW HEPARIN
K030964
Instrumentation Laboratory CO
Hematology · 71d
Cleared Nov 09, 2001
N LP(A) STANDARD SY
K013126
Dade Behring, Inc.
Chemistry · 51d
Cleared May 10, 2001
BECKMAN COULTER DNASE B CALIBRATOR
K010696
Beckman Coulter, Inc.
Immunology · 63d
Cleared Jan 25, 2001
ELECSYS HCG STAT CLASET II
K003941
Roche Diagnostics Corp.
Chemistry · 35d
Cleared Jan 12, 2001
ELECSYS CA 125 II CALSET
K003969
Roche Diagnostics Corp.
Immunology · 21d
Cleared Oct 05, 2000
ELECSYS DHEA-S CALSET
K002760
Roche Diagnostics Corp.
Chemistry · 30d
Cleared Aug 10, 2000
ELECSYS CA 15-3 CALCHECK
K002353
Roche Diagnostics Corp.
Immunology · 8d
Cleared Jul 13, 2000
ELECSYS INSULIN CALSET
K001906
Roche Diagnostics Corp.
Chemistry · 21d
Cleared Feb 10, 2000
SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR
K000331
Beckman Coulter, Inc.
Chemistry · 50d
Cleared Feb 03, 2000
SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR
K994168
Beckman Coulter, Inc.
Chemistry · 55d
Cleared Feb 03, 2000
SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR
K994169
Beckman Coulter, Inc.
Chemistry · 55d
Cleared Jan 20, 2000
DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR
K994114
Dade Behring, Inc.
Chemistry · 45d
Cleared Jan 12, 2000
SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR
K994325
Beckman Coulter, Inc.
Chemistry · 21d
Cleared Dec 21, 1998
SYNCHRON SYSTEMS LIPID CALIBRATOR
K983640
Beckman Coulter, Inc.
Chemistry · 66d
Cleared Jun 29, 1995
SYNCHRON ENZYME VALIDATOR SET
K951964
Beckman Instruments, Inc.
Chemistry · 63d
Cleared May 17, 1995
IMX ESTRADIOL
K951629
Abbott Laboratories
Chemistry · 61d
Cleared Jun 25, 1993
REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM
K922646
Behring Diagnostics, Inc.
Chemistry · 387d
Cleared Sep 23, 1992
DU PONT ACA MASS CREATIVE KINASE MB (MCKMB) CALIBR
K922699
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 111d
Cleared Sep 09, 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR
K922698
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 97d
Cleared Aug 12, 1992
DU PONT ACA PLUS IMMUNOASSSAY SYSTEM HCG CALIBRATO
K922696
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 69d

About Product Code JIS - Regulatory Context