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
49–72 of 302
Cleared Mar 22, 1994
ACA PLUS FERRITIN CALIBRATOR
K935543
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 126d
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 Feb 23, 1993
SYSTEMATE PLUS CALIBRATOR
K925101
Em Diagnostic Systems, Inc.
Chemistry · 138d
Cleared Jun 16, 1992
ROCHE CALIBRATOR SERUM
K922043
Roche Diagnostic Systems, Inc.
Chemistry · 46d
Cleared Jan 22, 1992
IL TEST(TM) CALIBRATION SET SP
K914909
Instrumentation Laboratory CO
Chemistry · 82d
Cleared Dec 13, 1991
DU PONT TOTAL PROTEIN/ALBUMIN CALIBRATOR
K914917
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 39d
Cleared Nov 22, 1991
ROCHE COBAS(R) AMMONIA AND ETHANOL CALIBRATOR
K914750
Roche Diagnostic Systems, Inc.
Chemistry · 31d
Cleared Mar 29, 1991
PARAMAX(R) ELECTROLYTE CALIBRATOR 1&2/MODIFICATION
K910309
Baxter Healthcare Corp
Chemistry · 64d
Cleared Sep 27, 1990
PARAMAX URINE/CSF CALIBRATOR LEVEL I AND II
K903913
Baxter Healthcare Corp
Chemistry · 34d
Cleared Jun 26, 1990
COBAS READY CALIBRATOR KIT
K897097
Roche Diagnostic Systems, Inc.
Chemistry · 187d
Cleared Mar 09, 1990
ROCHE STANDARDS FOR THE COBAS ISE MODULE
K897071
Roche Diagnostic Systems, Inc.
Chemistry · 77d
Cleared May 27, 1988
PARAMAX ALCOHOL AND AMMONIA CALIBRATOR, I & II
K881258
Baxter Healthcare Corp
Toxicology · 65d
Cleared Jan 05, 1988
PARAMAX URINE/CSF CALIBRATOR
K874587
Baxter Healthcare Corp
Chemistry · 57d
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 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 May 10, 1985
COBAS CALIBRATOR SERUM
K850859
Roche Diagnostic Systems, Inc.
Chemistry · 70d
Cleared Feb 27, 1985
ROCHE STANDARDS FOR CHLORIDE & CO2
K850396
Roche Diagnostic Systems, Inc.
Chemistry · 26d