JIT · Class II · 21 CFR 862.1150

FDA Product Code JIT: Calibrator, Secondary

Leading manufacturers include Dade Behring, Inc., Wako Chemicals USA, Inc. and Roche Diagnostics Corp..

245
Total
245
Cleared
59d
Avg days
1976
Since
245 devices
73–96 of 245
Cleared Aug 01, 2001
WAKO IMMUNOASSAY CALIBRATOR SET
K010332
Wako Chemicals USA, Inc.
Immunology · 180d
Cleared Jun 25, 2001
WAKO LIPID CALIBRATOR
K010334
Wako Chemicals USA, Inc.
Immunology · 143d
Cleared May 02, 2001
RAICHEM CREATININE URINE STANDARD
K011126
Hemagen Diagnostics, Inc.
Chemistry · 19d
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
Cleared Oct 27, 1998
FERRITIN CALIBRATOR
K983548
Dade Behring, Inc.
Immunology · 18d
Cleared Aug 13, 1998
PREALBUMIN CALIBRATOR
K982292
Dade Behring, Inc.
Chemistry · 44d
Cleared Apr 16, 1998
STRATUS CS CKMB CALPAK
K981097
Dade Behring, Inc.
Chemistry · 21d
Cleared Apr 16, 1998
STRATUS CS TROP CALPAK
K981100
Dade Behring, Inc.
Chemistry · 21d
Cleared Apr 15, 1998
STRATUS CS MYO CALPAK
K981101
Dade Behring, Inc.
Chemistry · 20d