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
289–312 of 673
Cleared Jun 24, 1997
ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN)
K972214
Roche Diagnostic Systems, Inc.
Chemistry · 12d
Cleared Jun 18, 1997
QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3
K972080
Consolidated Technologies, Inc.
Chemistry · 15d
Cleared Jun 16, 1997
SPECIALITY URINE 1,2
K971405
Chiron Diagnostics Corp.
Chemistry · 61d
Cleared Jun 16, 1997
LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600)
K971952
Bio-Rad
Chemistry · 19d
Cleared Jun 11, 1997
LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398)
K971954
Bio-Rad
Chemistry · 14d
Cleared Apr 23, 1997
LIQUID LIGAND 1,2,3
K971071
Chiron Diagnostics Corp.
Chemistry · 30d
Cleared Apr 08, 1997
SPINALSCOPICS
K970862
Quantimetrix Corp.
Chemistry · 32d
Cleared Apr 08, 1997
CERTAIN COMPLETE LEVELS 1,2, AND 3
K970956
Chiron Diagnostics Corp.
Chemistry · 22d
Cleared Apr 02, 1997
CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
K970976
Medical Analysis Systems, Inc.
Chemistry · 16d
Cleared Apr 02, 1997
LIQUID CSF(LCR)1, LIQUID CSF(LCR)2
K970979
Chiron Diagnostics Corp.
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 27, 1997
VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015)
K965048
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry · 40d
Cleared Jan 13, 1997
LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426)
K965171
Bio-Rad
Chemistry · 20d
Cleared Dec 13, 1996
CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1: IIBC-91 AND LEVEL 2: IIBC-92
K964640
Canyon Diagnostics, Inc.
Chemistry · 24d
Cleared Dec 05, 1996
BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS
K963770
Biocircuits Corp.
Chemistry · 77d
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 Sep 13, 1996
LIQUITROL-TM, TUMOR MARKER CONTROL, LEVEL 1 AND 2
K961359
Bioprocessing, Inc.
Immunology · 157d
Cleared Sep 09, 1996
STABILYPH UNASSAYED LIGAND ASSASY CONTROL, LEVELS 1, 2 AND 3
K963346
Consolidated Technologies, Inc.
Chemistry · 14d
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
QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET
K961912
Consolidated Technologies, Inc.
Immunology · 90d
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