JIS · Class II · 21 CFR 862.1150

FDA Product Code JIS: Calibrator, Primary

Leading manufacturers include E.I. Dupont DE Nemours & Co., Inc., Wako Chemicals USA, Inc. and Syva Co..

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 Aug 13, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS
K032296
Ortho-Clinical Diagnostics, Inc.
Chemistry · 19d
Cleared Jun 06, 2003
CALIBRATION PLASMA LMW HEPARIN
K030964
Instrumentation Laboratory CO
Hematology · 71d
Cleared Apr 11, 2003
WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET
K030320
Wako Chemicals USA, Inc.
Chemistry · 71d
Cleared Nov 05, 2002
RANDOX C-REACTIVE PROTEIN CALIBRATOR
K022682
Randox Laboratories, Ltd.
Chemistry · 85d
Cleared Sep 27, 2002
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS
K022901
Ortho-Clinical Diagnostics
Chemistry · 24d
Cleared Nov 09, 2001
N LP(A) STANDARD SY
K013126
Dade Behring, Inc.
Chemistry · 51d
Cleared Sep 28, 2001
RANDOX LIPOPROTEIN
K011568
Randox Laboratories, Ltd.
Chemistry · 130d
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 Jun 01, 2000
WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR
K001004
Wako Chemicals USA, Inc.
Chemistry · 64d
Cleared Jun 01, 2000
WAKO HDL-C/LDL-C CALIBRATOR
K001005
Wako Chemicals USA, Inc.
Chemistry · 64d
Cleared May 24, 2000
WAKO LIPASE CALIBRATOR
K001002
Wako Chemicals USA, Inc.
Chemistry · 56d
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

About Product Code JIS - Regulatory Context