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
313–336 of 673
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 May 02, 1996
QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2
K961293
Consolidated Technologies, Inc.
Chemistry · 28d
Cleared Apr 24, 1996
AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3
K955690
Clinical Controls, Inc.
Chemistry · 132d
Cleared Apr 24, 1996
SERUM VOLATILES CONTROL LEVEL 1 & 2
K955691
Clinical Controls, Inc.
Chemistry · 132d
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 Mar 12, 1996
SYSCON TURMOR MARKER CONTROL
K955812
Scantibodies Laboratory, Inc.
Chemistry · 77d
Cleared Feb 21, 1996
N/T PROTEIN CONTROL SY/L, M AND H
K955858
Behring Diagnostics, Inc.
Immunology · 56d
Cleared Feb 14, 1996
SYSCON CONTROL ASSAYED & UNASSAYED
K954247
Scantibodies Laboratory, Inc.
Chemistry · 156d
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
Cleared Aug 24, 1995
CSF LIQUID CEREBROSPINAL FLUID CONTROL
K952877
Medical Analysis Systems, Inc.
Chemistry · 62d
Cleared Jul 12, 1995
COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI
K942647
Scantibodies Laboratory, Inc.
Immunology · 404d
Cleared May 23, 1995
PROSTAT CONTROL
K943394
Quantimetrix Corp.
Immunology · 313d
Cleared May 16, 1995
LIQUICHEK(TM IMMUNOLOGY CONTROL, LEVELS 1.2. AND 3
K945651
Bio-Rad
Immunology · 180d
Cleared Apr 20, 1995
VIGIL MULTICHEK CONTROLS
K951170
Beckman Instruments, Inc.
Chemistry · 36d