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
169–192 of 302
Cleared Jun 09, 1992
CIBA CORNING ACS FOLATE IMMUNOASSAY
K921678
Ciba Corning Diagnostics Corp.
Chemistry · 62d
Cleared Jan 30, 1992
CALIBRATOR
K915797
Alko Diagnostic Corp.
Chemistry · 37d
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 Dec 26, 1990
ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR
K904767
Analytical Control Systems, Inc.
Chemistry · 65d
Cleared Sep 27, 1990
HI CHEM PROTEIN/LIPIDS LINEARITY
K903888
Hichem Diagnostics
Chemistry · 36d
Cleared Sep 27, 1990
PARAMAX URINE/CSF CALIBRATOR LEVEL I AND II
K903913
Baxter Healthcare Corp
Chemistry · 34d
Cleared Jul 31, 1990
MULTI ANALYTE MIXTURE, CALIBRATORS
K902675
Phoenix Diagnostics, Inc.
Chemistry · 42d
Cleared Jun 26, 1990
COBAS READY CALIBRATOR KIT
K897097
Roche Diagnostic Systems, Inc.
Chemistry · 187d
Cleared Mar 27, 1990
CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE
K897177
Nova Biomedical Corp.
Chemistry · 90d
Cleared Mar 09, 1990
ROCHE STANDARDS FOR THE COBAS ISE MODULE
K897071
Roche Diagnostic Systems, Inc.
Chemistry · 77d
Cleared Jan 11, 1990
SODIUM AND POTASSIUM STANDARD
K895717
Data Medical Associates, Inc.
Chemistry · 108d
Cleared Oct 23, 1989
HI CHEM CALIBRATOR A+
K895135
Hichem Diagnostics
Chemistry · 68d
Cleared Mar 13, 1989
HI CHEM CALIBRATION STANDARDS LEVELS 1 AND 2
K890583
Hichem Diagnostics
Chemistry · 35d
Cleared Aug 30, 1988
DC-LIQUICAL CATALOGUE #SE-030
K882258
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 91d
Cleared May 27, 1988
PARAMAX ALCOHOL AND AMMONIA CALIBRATOR, I & II
K881258
Baxter Healthcare Corp
Toxicology · 65d
Cleared Feb 17, 1988
QM300 CALIBRATOR B PACK
K875282
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 55d
Cleared Feb 03, 1988
BIOTROL CALIBRANT LEVEL 2
K875304
Biotrol, USA, Inc.
Chemistry · 36d
Cleared Feb 02, 1988
BIOTROL CALIBRANT LEVEL 1
K875288
Biotrol, USA, Inc.
Chemistry · 35d
Cleared Feb 02, 1988
BIOTROL CALIBRANT LEVEL 3
K875318
Biotrol, USA, Inc.
Chemistry · 35d
Cleared Jan 05, 1988
REAGENT A AND REAGENT B
K874413
Seradyn, Inc.
Chemistry · 69d
Cleared Jan 05, 1988
PARAMAX URINE/CSF CALIBRATOR
K874587
Baxter Healthcare Corp
Chemistry · 57d