JIX · Class II · 21 CFR 862.1150

FDA Product Code JIX: Calibrator, Multi-analyte Mixture

Leading manufacturers include Dade Behring, Inc., Roche Diagnostics Corp. and Roche Diagnostic Systems, Inc..

302
Total
302
Cleared
66d
Avg days
1976
Since
302 devices
25–48 of 302
Cleared Aug 18, 2003
MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
K032287
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Jul 16, 2003
AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL
K031880
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Sep 28, 2001
MODIFICATION TO N PROTEIN STANDARD SL
K012470
Dade Behring, Inc.
Chemistry · 57d
Cleared Jun 25, 2001
CALIBRATOR FOR AUTOMATED SYSTEMS
K011226
Roche Diagnostics Corp.
Chemistry · 66d
Cleared Jun 14, 2001
DIMENSION DRUG CALIBRATOR, MODEL DC22B
K011035
Dade Behring, Inc.
Chemistry · 70d
Cleared Oct 05, 2000
N PROTEIN STANDARD SL
K002804
Dade Behring, Inc.
Chemistry · 27d
Cleared Mar 21, 2000
ELECSYS CORTISOL CALCHECK
K000576
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Jun 01, 1999
MODIFICATION OF N PROTEIN STANDARD SL
K991181
Dade Behring, Inc.
Chemistry · 55d
Cleared Mar 22, 1999
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.)
K990460
Roche Diagnostics Corp.
Chemistry · 38d
Cleared Jan 20, 1999
MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR
K984425
Boehringer Mannheim Corp.
Chemistry · 40d
Cleared Dec 23, 1998
SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
K984014
Beckman Coulter, Inc.
Chemistry · 42d
Cleared Nov 25, 1998
PRECISET SERUM PROTEINS CALIBRATOR
K983469
Boehringer Mannheim Corp.
Chemistry · 55d
Cleared Jul 09, 1998
AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2
K981706
Abbott Laboratories
Chemistry · 56d
Cleared Jan 30, 1998
BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS
K974825
Boehringer Mannheim Corp.
Chemistry · 37d
Cleared Dec 15, 1997
BECKMAN CALIBRATOR 2 (CAL2)
K973932
Beckman Instruments, Inc.
Chemistry · 61d
Cleared Dec 01, 1997
BECKMAN URINE PROTEIN CALIBRATOR (UCAL)
K973928
Beckman Instruments, Inc.
Chemistry · 47d
Cleared Jun 03, 1997
SYNCHRON SYSTEMS CAL 5 PLUS
K971283
Beckman Instruments, Inc.
Immunology · 57d
Cleared May 23, 1997
SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYD
K971333
Beckman Instruments, Inc.
Chemistry · 43d
Cleared Dec 16, 1996
ELECSYS CALCHECK FSH
K964829
Boehringer Mannheim Corp.
Chemistry · 14d
Cleared Oct 29, 1996
CEDIA CARDIAC TDM MULTI-CALS
K962269
Boehringer Mannheim Corp.
Toxicology · 138d
Cleared Jun 13, 1996
CEDIA CORE TDM MULTI-CAL
K961659
Boehringer Mannheim Corp.
Toxicology · 44d
Cleared Oct 03, 1995
APOLIPOPROTEIN CALIBRATOR (APO-CAL)
K953979
Beckman Instruments, Inc.
Chemistry · 41d
Cleared Sep 20, 1995
ROCHE CALIBRATOR SERUM
K942706
Roche Diagnostic Systems, Inc.
Chemistry · 469d
Cleared Sep 15, 1995
ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR
K952282
Roche Diagnostic Systems, Inc.
Chemistry · 122d