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
505–528 of 673
Cleared May 29, 1986
STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III
K860906
American Dade
Toxicology · 80d
Cleared May 23, 1986
QUANTIMETRIX HUMAN BILIRUBIN CONTROL I & II LIQUID
K860942
Quantimetrix Corp.
Chemistry · 72d
Cleared May 23, 1986
THERACHEM-PLUS, TRI-LEVEL TDC (TM)
K861185
Fisher Scientific Co., LLC
Toxicology · 53d
Cleared May 23, 1986
CONTROL SERA LEVEL VALUES (MG/DL)
K861567
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 25d
Cleared May 23, 1986
IRON PROCEDURE
K861603
Data Medical Associates, Inc.
Chemistry · 24d
Cleared Apr 07, 1986
GILFORD UNIQUAL NORMAL CONTROL SERUM - ASSAYED
K861068
Ciba Corning Diagnostics Corp.
Chemistry · 18d
Cleared Apr 03, 1986
PRECINORM IM AND PRECIPATH IM
K860970
Boehringer Mannheim Corp.
Chemistry · 22d
Cleared Apr 03, 1986
GILFORD UNIQUAL ABNORMAL CONTROL SERUM/UNASSAYED
K860998
Ciba Corning Diagnostics Corp.
Chemistry · 16d
Cleared Apr 03, 1986
GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED
K861000
Ciba Corning Diagnostics Corp.
Chemistry · 16d
Cleared Mar 17, 1986
BOVINE CHEMISTRY CONTROL I.X AND II.X
K860355
American Dade
Chemistry · 46d
Cleared Jan 13, 1986
RANGE-CHEK
K854789
American Monitor Corp.
Chemistry · 45d
Cleared Oct 04, 1985
QUANTIMETRIX HUMAN SERUM CHEMISTRY CONTROL
K853931
Quantimetrix Corp.
Chemistry · 10d
Cleared Aug 02, 1985
DC LIQUITROL LEVEL 1 & 2
K852753
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 35d
Cleared Jul 12, 1985
DC-LIP, CATALOGUE NUMBER SE-020
K852594
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 23d
Cleared May 31, 1985
COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY
K851942
Coulter Electronics, Inc.
Chemistry · 28d
Cleared Apr 12, 1985
DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO
K850574
American Dade
Immunology · 58d
Cleared Apr 10, 1985
DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H
K850575
American Dade
Chemistry · 56d
Cleared Mar 05, 1985
PRECINORM H & PRECIPATH H
K850017
Boehringer Mannheim Corp.
Chemistry · 62d
Cleared Feb 27, 1985
ULTROSER G
K844413
Lkb Instruments, Inc.
Chemistry · 105d
Cleared Feb 06, 1985
PARAGON TRICHECK ELECTROPHORESIS CONTROL
K844996
Beckman Instruments, Inc.
Chemistry · 42d
Cleared Feb 06, 1985
GELMAN TRIPHOR CONTROL
K850202
Gelman Sciences, Inc.
Chemistry · 19d
Cleared Jan 08, 1985
LYPHOCHEK PREGNANCY CONTROL SERUM HUMAN
K844125
Bio-Rad
Chemistry · 77d
Cleared Sep 28, 1984
QUALIFY I & II AMER. MONITOR 2009 & 2010
K843611
American Monitor Corp.
Chemistry · 15d
Cleared Jul 06, 1984
KODAK EKTACHEM CONTROL
K841884
Eastman Kodak Company
Chemistry · 60d