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
145–168 of 245
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
Cleared Nov 02, 1994
FLUIDS PACK
K944516
Alko Diagnostic Corp.
Chemistry · 48d
Cleared Sep 14, 1994
LIPASE CALIBRATOR
K943704
The DU Pont Co.
Chemistry · 44d
Cleared Mar 11, 1994
URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR
K934843
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 154d
Cleared Nov 08, 1991
TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL
K913371
Creative Laboratory Products, Inc.
Chemistry · 102d
Cleared Mar 29, 1991
CHOLESTEROL CALIBRATOR SET
K910962
Casco Standards
Chemistry · 23d
Cleared Feb 27, 1991
ELECTROPHORESIS CONTROL
K910160
Seradyn, Inc.
Chemistry · 43d
Cleared Nov 28, 1990
SECONDARY CALIBRATORS
K904698
Bionostics, Inc.
Chemistry · 43d
Cleared Jan 18, 1990
COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN.
K895648
Ventrex Laboratories, Inc.
Chemistry · 120d
Cleared Jan 18, 1990
COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN.
K895649
Ventrex Laboratories, Inc.
Chemistry · 120d
Cleared Oct 31, 1989
OSMOMETER STANDARD SOLUTIONS
K892329
D.R.G. Scientific Industries
Chemistry · 209d
Cleared Aug 15, 1989
CHLORIDE STANDARDS ITEM #SR1041
K891999
Em Diagnostic Systems, Inc.
Chemistry · 140d
Cleared Jul 20, 1989
DOCUMENT(TM) URIC ACID LINEARITY TEST SET
K893139
Casco Standards
Chemistry · 86d
Cleared Dec 14, 1988
DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET
K884197
Casco Standards
Chemistry · 69d
Cleared Oct 25, 1988
BILIRUBIN STANDARD
K882059
Verichem Laboratories, Inc.
Chemistry · 162d
Cleared Oct 06, 1988
BINAS LUTEINIZING HORMONE IRMA TEST KIT
K883306
Binax, Inc.
Chemistry · 63d