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
217–240 of 673
Cleared Apr 08, 1997
SPINALSCOPICS
K970862
Quantimetrix Corp.
Chemistry · 32d
Cleared Apr 02, 1997
CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
K970976
Medical Analysis Systems, Inc.
Chemistry · 16d
Cleared Feb 20, 1997
TUMOR MARKER CONTROL
K965114
Diagnostic Products Corp.
Immunology · 62d
Cleared Feb 10, 1997
ELECSYS CALCHECK PROLACTIN
K970147
Boehringer Mannheim Corp.
Chemistry · 26d
Cleared Jan 13, 1997
LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426)
K965171
Bio-Rad
Chemistry · 20d
Cleared Nov 06, 1996
N/T PROTEIN CONTROL SL
K964065
Behring Diagnostics, Inc.
Chemistry · 27d
Cleared Sep 16, 1996
LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363
K961941
Bio-Rad
Chemistry · 119d
Cleared Aug 23, 1996
NOVA CHEMISTRY CONTROLS, LEVEL 1,2,AND 3 W/O CREAT
K962982
Nova Biomedical Corp.
Chemistry · 22d
Cleared Aug 15, 1996
NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3
K962997
Nova Biomedical Corp.
Chemistry · 13d
Cleared Jul 22, 1996
DOCUMENT CARDIAC ASSAYED CONTROL
K961750
Casco Standards
Chemistry · 77d
Cleared Jul 22, 1996
ELECSYS PRECICONTROL CARDIAC
K962575
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Jul 22, 1996
DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL
K962630
Casco Standards
Chemistry · 17d
Cleared May 15, 1996
CHEM-CHEX STAT
K961195
Streck Laboratories, Inc.
Chemistry · 49d
Cleared Apr 23, 1996
IMMUNOLOGY CONTROL
K960824
Medical Analysis Systems, Inc.
Chemistry · 54d
Cleared Apr 03, 1996
LIPID CONTROL
K960862
Medical Analysis Systems, Inc.
Chemistry · 33d
Cleared Feb 21, 1996
N/T PROTEIN CONTROL SY/L, M AND H
K955858
Behring Diagnostics, Inc.
Immunology · 56d
Cleared Feb 02, 1996
NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 4
K955252
Nova Biomedical Corp.
Chemistry · 79d
Cleared Feb 02, 1996
NOVA CHEMISTRY PERFORMANCE CHECK SOLUTION
K955260
Nova Biomedical Corp.
Chemistry · 79d
Cleared Feb 02, 1996
NOVA CHEMISTRY CONTROLS, LEVELS 1 AND 2
K955264
Nova Biomedical Corp.
Chemistry · 79d
Cleared Dec 21, 1995
ROCHE CONTROL SERUM N
K954655
Roche Diagnostic Systems, Inc.
Immunology · 72d
Cleared Dec 21, 1995
ROCHE CONTROL SERUM P
K954656
Roche Diagnostic Systems, Inc.
Immunology · 72d
Cleared Nov 28, 1995
LIQUICHEK ETHANOL/AMMONIA CONTROL
K955024
Bio-Rad
Chemistry · 26d
Cleared Nov 09, 1995
MAS LIQUID URINALYSIS CONTROL
K954323
Medical Analysis Systems, Inc.
Chemistry · 55d
Cleared Oct 07, 1995
AALTO SCIENTIFIC LIQUID CARDIAC CONTROL
K954074
Aalto Scientific, Ltd.
Chemistry · 38d