JJY · Class I · 21 CFR 862.1660

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

Leading manufacturers include Bio-Rad, Roche Diagnostics Corp. and Boehringer Mannheim Corp..

673
Total
673
Cleared
64d
Avg days
1976
Since
673 devices
73–96 of 673
Cleared Aug 12, 1998
TUMOR MARKER CONTROL
K982473
Diagnostic Products Corp.
Immunology · 27d
Cleared Aug 12, 1998
IMMULITE PSA CONTROL MODULE, MODEL LPSCM
K982637
Diagnostic Products Corp.
Immunology · 14d
Cleared Jul 09, 1998
VIGIL PROTEIN CONTROL
K982224
Beckman Coulter, Inc.
Chemistry · 15d
Cleared May 18, 1998
BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS
K981401
Boehringer Mannheim Corp.
Chemistry · 31d
Cleared May 13, 1998
THIRD GENERATION PSA CONTROL MODULE
K981455
Diagnostic Products Corp.
Chemistry · 20d
Cleared May 12, 1998
LYPHOCHEK IMMUNOASSAY PLUS CONTROL
K981532
Bio-Rad
Chemistry · 13d
Cleared Jan 22, 1998
BM PRECIPATH(R) HDL/LDL-C CONTROL
K974826
Boehringer Mannheim Corp.
Chemistry · 29d
Cleared Dec 17, 1997
VIGIL LIPID CONTROL
K974452
Beckman Instruments, Inc.
Chemistry · 22d
Cleared Dec 08, 1997
ELECSYS CALCHECK FOLATE
K974384
Boehringer Mannheim Corp.
Chemistry · 17d
Cleared Oct 07, 1997
PRECINORM RF, PRECIPATH RF
K973629
Boehringer Mannheim Corp.
Immunology · 13d
Cleared Aug 12, 1997
PRECICONTROL TUMOR MARKER 1 AND 2
K972235
Boehringer Mannheim Corp.
Immunology · 57d
Cleared Jun 24, 1997
ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN)
K972214
Roche Diagnostic Systems, Inc.
Chemistry · 12d
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 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 Sep 16, 1996
LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363
K961941
Bio-Rad
Chemistry · 119d
Cleared Jul 22, 1996
ELECSYS PRECICONTROL CARDIAC
K962575
Boehringer Mannheim Corp.
Chemistry · 21d
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 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