JJY · Class I · 21 CFR 862.1660

FDA Product Code JJY: Multi-analyte Controls, All Kinds (assayed)

Leading manufacturers include Bio-Rad, Medical Analysis Systems, Inc. and Cliniqa Corporation.

673
Total
673
Cleared
64d
Avg days
1976
Since
673 devices
409–432 of 673
Cleared May 22, 1991
CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE
K911755
Bionostics, Inc.
Chemistry · 34d
Cleared May 15, 1991
HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED
K911803
Hichem Diagnostics
Chemistry · 22d
Cleared May 10, 1991
DOCUMENT REFLECTANCE II LINEARITY TEST SET
K910440
Casco Standards
Chemistry · 99d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONIT CONTR, SET II, LEVEL I
K911169
Analytical Control Systems, Inc.
Toxicology · 47d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONIT CONTR, SET II LEVEL III
K911171
Analytical Control Systems, Inc.
Toxicology · 47d
Cleared Jan 23, 1991
CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-II
K904989
Creative Laboratory Products, Inc.
Chemistry · 77d
Cleared Dec 26, 1990
CHEM-CHEX LIPID
K905389
Streck Laboratories, Inc.
Chemistry · 26d
Cleared Dec 18, 1990
CHOLESTECH L.D.X. LEVEL 1 CONTROL
K904784
Cholestech Corp.
Chemistry · 57d
Cleared Dec 07, 1990
LDL-DIRECT CONTROLS
K902740
Isolab, Inc.
Chemistry · 168d
Cleared Dec 07, 1990
HDL CHOLESTEROL CONTROL
K904872
Analytical Control Systems, Inc.
Chemistry · 38d
Cleared Dec 06, 1990
CLINICAL CHEMISTRY CONTROL
K904075
Phoenix Diagnostics, Inc.
Chemistry · 93d
Cleared Dec 06, 1990
ACS CHOLESTEROL/TRIGLYCERIDE LIQUID CONTROL
K904829
Analytical Control Systems, Inc.
Chemistry · 42d
Cleared Dec 06, 1990
QCLYTE PROTEIN BASED ISE CONTROL
K904968
Baxter Healthcare Corp
Chemistry · 31d
Cleared Nov 09, 1990
KODATROL I AND II CONTROL AND DILUENT SET
K904768
Eastman Kodak Company
Chemistry · 18d
Cleared Nov 01, 1990
TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III
K904141
Medical Analysis Systems, Inc.
Chemistry · 56d
Cleared Oct 26, 1990
URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS
K904099
Hichem Diagnostics
Chemistry · 50d
Cleared Oct 12, 1990
HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237)
K904293
Hichem Diagnostics
Chemistry · 23d
Cleared Oct 04, 1990
DADE(R) CSF.L, LIQ CEREBROSPIN FLUID CTRL LEV 1&2
K903933
Baxter Healthcare Corp
Chemistry · 38d
Cleared Sep 24, 1990
DADE IMMUNOASSAY CONTROLS, LEVELS I, II, III
K903566
Baxter Healthcare Corp
Immunology · 48d
Cleared Sep 07, 1990
CHALLENGE(TM) BRAND LIQ MULTI-ANALYTE LINEAR CONTR
K903310
Medical Analysis Systems, Inc.
Chemistry · 45d
Cleared Sep 07, 1990
AFFINITY HLH TEST SYSTEM
K903407
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 38d
Cleared Aug 22, 1990
CLP LOW LEVEL HDL CHOLESTEROL -LIPID CONTROL
K902909
Creative Laboratory Products, Inc.
Chemistry · 50d
Cleared Aug 17, 1990
MONI-TROL XL AND L UNASSAYED LIQUID CHEMISTRY
K903190
Medical Analysis Systems, Inc.
Chemistry · 29d
Cleared Aug 17, 1990
CHALLENGE BRAND LIQUID MULTI-ENZYME LINEARITY CONT
K903225
Medical Analysis Systems, Inc.
Chemistry · 25d