JIX · Class II · 21 CFR 862.1150

FDA Product Code JIX: Calibrator, Multi-analyte Mixture

Leading manufacturers include Alko Diagnostic Corp., Dade Behring, Inc. and Bhp Diagnostix, Inc..

302
Total
302
Cleared
66d
Avg days
1976
Since
302 devices
145–168 of 302
Cleared Sep 06, 1994
FLUIDS PACK FOR CORING 238
K940760
Alko Diagnostic Corp.
Chemistry · 200d
Cleared Aug 09, 1994
DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR
K941219
Dupont Medical Products
Chemistry · 148d
Cleared Jul 28, 1994
ALKO FLUIDS PACKS FOR NOVA 8 ANALYZERS
K942549
Alko Diagnostic Corp.
Chemistry · 58d
Cleared Apr 21, 1994
SYNERMEDIR CAL I AND SYNERMED IR CAL II
K940571
Synermed, Inc.
Chemistry · 72d
Cleared Mar 28, 1994
ALKO REAGENTS FOR BAXTER PARAMAX CHEMISTRY SYSTEM
K934607
Alko Diagnostic Corp.
Chemistry · 182d
Cleared Mar 22, 1994
ACA PLUS FERRITIN CALIBRATOR
K935543
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 126d
Cleared Mar 09, 1994
REAGENTS FOR HITACHI ISE
K933383
Alko Diagnostic Corp.
Chemistry · 270d
Cleared Jan 18, 1994
REAGENTS FOR ORION 1020, AND RELATED ANALYZERS
K935018
Alko Diagnostic Corp.
Chemistry · 90d
Cleared Jan 18, 1994
CAL 1 AND CAL 2 STANDARDS/STANDARDS FOR IL 501 SODIUM/POTASSIUM ANALYZER
K935547
Alko Diagnostic Corp.
Chemistry · 62d
Cleared Jan 13, 1994
REAGENTS FOR ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA)
K925385
Alko Diagnostic Corp.
Chemistry · 444d
Cleared Jan 13, 1994
CALIBRATION SOLUTIONS FOR USE ON ELECTROLYTE INSTR
K925464
Alko Diagnostic Corp.
Chemistry · 441d
Cleared Jan 13, 1994
ALKO FLUIDS PACKS FOR NOVA ANALYZERS
K930199
Alko Diagnostic Corp.
Toxicology · 364d
Cleared Jan 13, 1994
ALKO CALIBRATION FOR AMDEV LYTENING SYSTEMS
K930231
Alko Diagnostic Corp.
Chemistry · 359d
Cleared Dec 09, 1993
QUANTIMETRIX BLOOD GLUCOSE CONTROLS
K932623
Quantimetrix Corp.
Chemistry · 191d
Cleared Dec 02, 1993
REAGENTS FOR COBAS ISE MODULE
K934701
Alko Diagnostic Corp.
Chemistry · 63d
Cleared Nov 05, 1993
N-ASSAY TIA MICROALBUMIN CALIBRATOR SET
K934143
Crestat Diagnostics, Inc.
Chemistry · 73d
Cleared Oct 18, 1993
CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323
K932768
Helena Laboratories
Chemistry · 132d
Cleared Oct 13, 1993
SIGMA CX-3 CALIBRATION STANDARD LEVEL 2
K933693
Sigma Chemical Co.
Chemistry · 76d
Cleared Oct 13, 1993
DUPONT STANDARD C FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM
K933955
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 62d
Cleared Oct 08, 1993
SIGMA CX-3 CALIBRATION STANDARD LEVEL 1
K933702
Sigma Chemical Co.
Chemistry · 71d
Cleared Aug 23, 1993
ACE CLINICAL CHEMISTRY SYSTEM
K930104
Schiapparelli Biosystems, Inc.
Chemistry · 224d
Cleared Feb 23, 1993
SYSTEMATE PLUS CALIBRATOR
K925101
Em Diagnostic Systems, Inc.
Chemistry · 138d
Cleared Jan 28, 1993
ISE CALIBRATOR FOR DUPONT DIMENSION
K926518
Alko Diagnostic Corp.
Chemistry · 29d
Cleared Jun 16, 1992
ROCHE CALIBRATOR SERUM
K922043
Roche Diagnostic Systems, Inc.
Chemistry · 46d