JIT · Class II · 21 CFR 862.1150

FDA Product Code JIT: Calibrator, Secondary

Leading manufacturers include Dade Behring, Inc., E.I. Dupont DE Nemours & Co., Inc. and Roche Diagnostics Corp..

245
Total
245
Cleared
59d
Avg days
1976
Since
245 devices
25–48 of 245
Cleared Sep 30, 2004
ELECSYS FOLATE II CALSET II
K042490
Roche Diagnostics Corp.
Chemistry · 16d
Cleared Oct 06, 2003
ABBOTT ARCHITECT ESTRADIOL CALIBRATORS
K032458
Abbott Laboratories
Chemistry · 56d
Cleared May 12, 2003
ELECSYS LH CALSET II
K031299
Roche Diagnostics Corp.
Chemistry · 18d
Cleared Jun 21, 2002
DIMENSION TPSA CALIBRATOR, MODEL #RC459
K020980
Dade Behring, Inc.
Immunology · 87d
Cleared May 08, 2002
DIMENSION ALDL CALIBRATOR, MODEL DC131
K020723
Dade Behring, Inc.
Chemistry · 63d
Cleared Oct 16, 2001
ACCESS UNCONJUGATED ESTRIOL CALIBRATORS
K012900
Beckman Coulter, Inc.
Chemistry · 48d
Cleared Sep 11, 2001
STRATUS CS TROPONIN I CALIBRATOR
K012233
Dade Behring, Inc.
Chemistry · 57d
Cleared Aug 24, 2001
MODIFICATION TO ELECSYS FSH II CALSET
K012399
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Apr 20, 2001
DIMENSION CTNI CALIBRATOR
K010314
Dade Behring, Inc.
Chemistry · 77d
Cleared Mar 15, 2001
N PROTEIN STANDARD UY CALIBRATOR
K003501
Dade Behring, Inc.
Chemistry · 122d
Cleared Mar 01, 2001
ELECSYS TESTOSTERONE CALSET II
K003411
Roche Diagnostics Corp.
Chemistry · 119d
Cleared Feb 20, 2001
DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137
K010208
Dade Behring, Inc.
Chemistry · 28d
Cleared Jan 26, 2001
ELECSYS FSH CALSET II
K003409
Roche Diagnostics Corp.
Chemistry · 85d
Cleared Nov 20, 2000
ACCESS ULTRASENSITIVE HGH CALIBRATORS
K003098
Beckman Coulter, Inc.
Chemistry · 48d
Cleared Mar 01, 2000
DIMENSION SPECIAL PROTEIN CALIBRATOR
K994291
Dade Behring, Inc.
Immunology · 71d
Cleared Sep 24, 1999
ELECSYS ESTRADIOL CALSET II
K992981
Roche Diagnostics Corp.
Chemistry · 21d
Cleared Jul 15, 1999
N PROTEIN STANDARD UY
K991705
Dade Behring, Inc.
Chemistry · 57d
Cleared Jul 01, 1999
OPUS TROPONIN I CALIBRATOR
K991176
Dade Behring, Inc.
Chemistry · 85d
Cleared Apr 16, 1999
REVISED C-REACTIVE PROTEIN CALIBRATOR
K990824
Dade Behring, Inc.
Immunology · 35d
Cleared Mar 22, 1999
DIMENSION SPECIAL PROTEIN CALIBRATOR
K990554
Dade Behring, Inc.
Immunology · 28d
Cleared Dec 14, 1998
DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR
K984193
Dade Behring, Inc.
Chemistry · 21d
Cleared Nov 18, 1998
DIMENSION AHDL CALIBRATOR
K983850
Dade Behring, Inc.
Chemistry · 19d
Cleared Nov 04, 1998
DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR
K983693
Dade Behring, Inc.
Chemistry · 14d
Cleared Nov 04, 1998
STRATUS CS TROPONIN I CALIBRATOR
K983722
Dade Behring, Inc.
Chemistry · 14d