JIT · Class II · 21 CFR 862.1150

FDA Product Code JIT: Calibrator, Secondary

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

245
Total
245
Cleared
59d
Avg days
1976
Since
245 devices
121–144 of 245
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 18, 1998
OLYMPUS SERUM PROTEIN MULTICALIBRATOR,
K981854
Olympus Diagnostica GmbH
Chemistry · 84d
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
Cleared Oct 20, 1997
CARDIAC TROPONIN-I (TROP) CALIBRATOR
K973668
Dade Intl., Inc.
Chemistry · 25d
Cleared Sep 29, 1997
PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR
K973100
Dade Chemistry Systems, Inc.
Immunology · 41d
Cleared Jun 16, 1997
ELECSYS CEA ASSAY
K964368
Boehringer Mannheim Corp.
Immunology · 227d
Cleared Mar 03, 1997
MMB CALIBRATOR
K970336
Dade Chemistry Systems, Inc.
Chemistry · 33d
Cleared Feb 18, 1997
THYROID CALIBRATOR
K970389
Dade Chemistry Systems, Inc.
Chemistry · 15d
Cleared Dec 03, 1996
FERRITIN CALIBRATOR
K963493
Dade Chemistry Systems, Inc.
Chemistry · 91d
Cleared Aug 15, 1996
ACA PLUS FT4 CALIBRATOR
K962594
Dade Intl., Inc.
Chemistry · 44d
Cleared Jul 23, 1996
STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY
K954326
Solarcare Technologies Corp,Inc.
Chemistry · 312d
Cleared Aug 31, 1995
DUPONT LIPASE CALIBRATOR
K952815
Dupont Medical Products
Chemistry · 72d