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
121–144 of 302
Cleared May 23, 1997
SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYD
K971333
Beckman Instruments, Inc.
Chemistry · 43d
Cleared Apr 08, 1997
STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0)
K970921
Alko Diagnostic Corp.
Chemistry · 27d
Cleared Jan 15, 1997
N RHEUMATOLOGY STANDARD SL
K964527
Behring Diagnostics, Inc.
Immunology · 64d
Cleared Dec 16, 1996
ELECSYS CALCHECK FSH
K964829
Boehringer Mannheim Corp.
Chemistry · 14d
Cleared Nov 21, 1996
N PROTEIN STRANDARD SL
K964062
Behring Diagnostics, Inc.
Chemistry · 42d
Cleared Oct 30, 1996
SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2
K963543
Sigma Diagnostics, Inc.
Chemistry · 56d
Cleared Oct 29, 1996
CEDIA CARDIAC TDM MULTI-CALS
K962269
Boehringer Mannheim Corp.
Toxicology · 138d
Cleared Oct 29, 1996
SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1
K963533
Sigma Diagnostics, Inc.
Chemistry · 55d
Cleared Sep 13, 1996
DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR
K962629
Casco Standards
Chemistry · 70d
Cleared Jul 16, 1996
N CRP STANDARD SY
K962406
Behring Diagnostics, Inc.
Chemistry · 25d
Cleared Jul 16, 1996
N PROTEIN STANDARD PY
K962410
Behring Diagnostics, Inc.
Hematology · 25d
Cleared Jun 21, 1996
CALIBRATION SERUM LEVEL 1 & 2
K955489
Randox Laboratories, Ltd.
Chemistry · 207d
Cleared Jun 13, 1996
CEDIA CORE TDM MULTI-CAL
K961659
Boehringer Mannheim Corp.
Toxicology · 44d
Cleared Apr 26, 1996
DADE MONI-TROL CANDIDATE PRODUCT COMBINATIONS
K960103
Dade Intl., Inc.
Chemistry · 106d
Cleared Mar 11, 1996
ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS
K960085
Alko Diagnostic Corp.
Chemistry · 60d
Cleared Dec 11, 1995
CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT
K955154
Alko Diagnostic Corp.
Chemistry · 28d
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
Cleared Sep 06, 1995
HICHEM ISE STANDARDS KIT 70011
K953863
Hichem Diagnostics
Chemistry · 20d
Cleared Feb 10, 1995
ALKO CAL PACKS FOR CORNING 654 ANALYZERS
K944922
Alko Diagnostic Corp.
Chemistry · 127d
Cleared Feb 10, 1995
ALKO CALIBRATORS AND FLUSH SOLUTION FOR IL 1300 SERIES PH/BLOOD GAS ANALYZERS
K945966
Alko Diagnostic Corp.
Chemistry · 65d
Cleared Nov 28, 1994
CALIBRATOR
K943012
Prisma Systems
Toxicology · 157d
Cleared Nov 15, 1994
DOCUMENTR AMMONIA/ETHANOLCALIBRATOR
K944639
Casco Standards
Chemistry · 55d