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
193–216 of 302
Cleared Nov 23, 1987
PROTEIN STANDARD CALIBRATOR
K871755
Wako Chemicals USA, Inc.
Chemistry · 202d
Cleared Sep 02, 1987
PARAMAX URINE/CSF CALIBRATOR
K872789
American Dade
Chemistry · 50d
Cleared Sep 02, 1987
MULTI ANALYTE MIXTURES, CALIBRATORS
K873116
Biotrol, USA, Inc.
Chemistry · 23d
Cleared Sep 02, 1987
BIOTROL REFERENCE
K873118
Biotrol, USA, Inc.
Chemistry · 23d
Cleared May 21, 1987
QM300 CALIBRATOR A PACK
K871341
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 49d
Cleared May 12, 1987
EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95
K871638
Em Diagnostic Systems, Inc.
Chemistry · 15d
Cleared May 08, 1987
IRON & MAGNESIUM ADDITIONS/REFERRIL B CALIBRATOR
K871664
Instrumentation Laboratory CO
Chemistry · 10d
Cleared Feb 13, 1987
DU PONT LIQUID MULTI-ANALYTE CALIBRATOR
K864909
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 60d
Cleared Oct 21, 1986
SOLUTION B- NA 50MEQ/L, K 40 MEQ/L
K863502
Reagent Laboratory, Inc.
Chemistry · 42d
Cleared Sep 29, 1986
PARAMAX ELECTROLYTE CALIBRATOR
K863489
American Dade
Chemistry · 20d
Cleared Sep 26, 1986
ACE II (TRI-LEVEL)
K863095
Medical Analysis Systems, Inc.
Chemistry · 44d
Cleared Aug 19, 1986
SERACON(TM) CAL (PRODUCT NO. DO35)
K862594
Bhp Diagnostix, Inc.
Chemistry · 42d
Cleared Aug 04, 1986
EMDS(TM) ELEVATED LIPID CALIBRATOR #67626/95
K862703
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared Jul 29, 1986
DU PONT DRUG CALIBRATOR
K861786
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 82d
Cleared Apr 07, 1986
EMDS CHEMISTRY CALIBRATORS, LEVELS I & II
K860765
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Mar 14, 1986
QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A
K855014
Kallestad Laboratories, Inc.
Immunology · 88d
Cleared Feb 19, 1986
PARAMAX COMPREHENSIVE CALIBRATOR
K855199
American Dade
Chemistry · 54d
Cleared Oct 25, 1985
DMA CALIBRATORS
K854092
Data Medical Associates, Inc.
Chemistry · 18d
Cleared Jun 25, 1985
INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU
K851990
Alpkem Corp.
Chemistry · 49d
Cleared Jun 14, 1985
CORNING CERTAIN -ISE
K851939
Corning Medical & Scientific
Chemistry · 42d
Cleared May 20, 1985
FISHER DIAGNOSTICS KDA CALIBRATOR I
K851150
Fisher Scientific Co., LLC
Chemistry · 60d
Cleared May 20, 1985
FISHER DIAGNOSTICS KDA CALIBRATOR II
K851151
Fisher Scientific Co., LLC
Chemistry · 60d
Cleared May 10, 1985
COBAS CALIBRATOR SERUM
K850859
Roche Diagnostic Systems, Inc.
Chemistry · 70d
Cleared Apr 01, 1985
CALIBRATOR B 88133
K850405
Hi Chem, Inc.
Chemistry · 56d