JJY · Class I · 21 CFR 862.1660

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

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

673
Total
673
Cleared
64d
Avg days
1976
Since
673 devices
121–144 of 673
Cleared Sep 07, 1990
AFFINITY HLH TEST SYSTEM
K903407
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 38d
Cleared Jul 10, 1990
PRECINORM(R) IM NORMAL IMMUNOASSAY CONTROL SERUM
K902536
Boehringer Mannheim Corp.
Chemistry · 33d
Cleared Jul 10, 1990
PRECIPATH(R) IM ABNORMAL IMMUNASSAY CONTROL SERUM
K902573
Boehringer Mannheim Corp.
Chemistry · 33d
Cleared Feb 02, 1990
DADE(R) TDM CONTROL
K892642
Baxter Healthcare Corp
Toxicology · 296d
Cleared Jan 18, 1990
LYPHOCHEK WHOLE BLOOD CONTROL (HUMAN) LEVELS 1,2,3
K895905
Bio-Rad
Toxicology · 104d
Cleared Sep 28, 1989
SERACHEM PLUS CLINICAL CHEMISTRY CONTROLS
K894852
Instrumentation Laboratory CO
Chemistry · 59d
Cleared Aug 11, 1989
LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II
K894078
Bio-Rad
Chemistry · 56d
Cleared Aug 01, 1989
LYPHOCHEK IMMUNOASSAY PLUS CONTROL SERUM
K894252
Bio-Rad
Immunology · 42d
Cleared Jul 20, 1989
DADE LIPID-TROL
K893580
Baxter Healthcare Corp
Chemistry · 72d
Cleared Jun 13, 1989
LYPHOCHEK TUMOR MARKER CONTROLS, LEVELS I AND II
K891680
Bio-Rad
Immunology · 84d
Cleared May 09, 1989
MONI-TROL(R)
K891929
Baxter Healthcare Corp
Immunology · 42d
Cleared Mar 15, 1989
RIATRAC PLUS
K890470
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 43d
Cleared Oct 25, 1988
LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II
K882486
Bio-Rad
Chemistry · 131d
Cleared Jul 21, 1988
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (BOVINE)I/II
K882542
Bio-Rad
Chemistry · 30d
Cleared Jul 08, 1988
MODIFIED DADE COMPRE. ELECTROPHORESIS CONTROL
K881503
Baxter Healthcare Corp
Chemistry · 88d
Cleared May 27, 1988
AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693
K881229
Em Diagnostic Systems, Inc.
Chemistry · 66d
Cleared Mar 03, 1988
LYPHOCHEK SPINAL FLUID CONTROL (HUMAN)
K880494
Bio-Rad
Chemistry · 28d
Cleared Mar 01, 1988
DADE(R) CK/LD COMPREHENSIVE ELECTRO. CONTROL
K880175
Baxter Healthcare Corp
Chemistry · 46d
Cleared Feb 18, 1988
LYPHOCHEK WHOLE BLOOD CONTROL
K874731
Bio-Rad
Chemistry · 92d
Cleared Jan 21, 1988
LYPHOCHEK ASSAYED CHEMISTRY CONTROL (HUMAN), I/II
K874280
Bio-Rad
Chemistry · 93d
Cleared Nov 23, 1987
PRECINORM L
K874230
Boehringer Mannheim Corp.
Chemistry · 39d
Cleared Jul 06, 1987
LIQUICHEK PEDIATRIC CONTROL LEVELS I AND II
K872227
Bio-Rad
Chemistry · 27d
Cleared Aug 04, 1986
LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL
K862185
Bio-Rad
Chemistry · 56d
Cleared May 23, 1986
CONTROL SERA LEVEL VALUES (MG/DL)
K861567
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 25d