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
553–576 of 673
Cleared Nov 24, 1981
ORTHO UNASSAYED CONTROL SERUM LEVEL II
K813167
Ortho Diagnostic Systems, Inc.
Chemistry · 12d
Cleared Nov 02, 1981
DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C
K812556
American Dade
Immunology · 55d
Cleared Oct 19, 1981
BECKMAN ICS NORMAL CONTROL SERA
K812650
Beckman Instruments, Inc.
Chemistry · 32d
Cleared Sep 24, 1981
BOVINE CHEMISTRY CONTROL I.X. & II.X.
K812583
American Dade
Chemistry · 14d
Cleared Jul 01, 1981
HELENA FETAL-TEK 200 MARKER
K811695
Helena Laboratories
Chemistry · 15d
Cleared Jun 12, 1981
IMIPRAMINE/DISIPRAMINE/LITHIUM
K811465
Ortho Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Jun 12, 1981
AMITRIPTYLINE/NORTRIPTYLINE/LITHIUM
K811466
Ortho Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Jun 12, 1981
DOXEPIN/DESMETHLDOXEPIN/LITHIUM
K811467
Ortho Diagnostic Systems, Inc.
Chemistry · 17d
Cleared May 15, 1981
MULTIANALYTE CONTROLS, ALL KINDS
K811182
Fisher Scientific Co., LLC
Chemistry · 17d
Cleared May 01, 1981
GELMAN ELECTROPHORESIS CONTROL
K811100
Gelman Sciences, Inc.
Chemistry · 9d
Cleared Apr 17, 1981
CORNING VITAMIN B12 FOLATE DEFIC. CONTR.
K810952
Corning Medical & Scientific
Chemistry · 10d
Cleared Apr 14, 1981
TRI-LEVEL NDI CONTROL
K810906
Nuclear Diagnostics, Inc.
Chemistry · 11d
Cleared Jan 09, 1981
TRI-LEVEL RADIOASSAY CONTROL SERA
K803098
American Diagnostic Corp.
Chemistry · 32d
Cleared Oct 10, 1980
KEMTROL SERUM CONTROL-NORMAL
K802108
Helena Laboratories
Chemistry · 37d
Cleared Oct 10, 1980
KEMTROL SERUM CONTROL ABNORMAL
K802109
Helena Laboratories
Chemistry · 37d
Cleared Sep 09, 1980
ASSURE LEVEL I PROD. #30171
K801538
Warner-Lambert Co.
Chemistry · 68d
Cleared Sep 09, 1980
ASSURE LEVEL II PROD. #30172
K801539
Warner-Lambert Co.
Chemistry · 68d
Cleared Jul 08, 1980
UNASSAYED CHEMISTRY SERUM CONTROL(BOVINE
K801335
Warner-Lambert Co.
Chemistry · 34d
Cleared Apr 24, 1980
DIAGNOSTIC PRODUCTS CORP. RIA CONTROL
K800813
Diagnostic Products Corp.
Chemistry · 13d
Cleared Mar 25, 1980
LIPID CONTROL PRODUCT # ACS LC 101
K800558
Analytical Control Systems, Inc.
Chemistry · 13d
Cleared Mar 25, 1980
SERTROL PRODUCT # ACS ST 101
K800559
Analytical Control Systems, Inc.
Chemistry · 13d
Cleared Mar 12, 1980
CK/LD ISOENZYME CONTROL PROD. #ACS CT101
K800370
Analytical Control Systems, Inc.
Chemistry · 21d
Cleared Oct 30, 1979
LIPOTROL
K792024
Helena Laboratories
Chemistry · 21d
Cleared Oct 30, 1979
LYOPHILIZED HDL CHOLESTEROL CONTROLS
K792025
Helena Laboratories
Chemistry · 21d