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
529–552 of 673
Cleared Jun 22, 1984
NOVA STAT CONTROL LEVELS 1/2/3
K841452
Nova Biomedical Corp.
Chemistry · 74d
Cleared Apr 17, 1984
BIOTIS ABNORMAL CLINICAL CHEM SERUM-
K840458
Otisville Biotech, Inc.
Microbiology · 75d
Cleared Apr 13, 1984
NORMAL CLINICAL CHEM. CONTROL SERUM-
K840457
Otisville Biotech, Inc.
Microbiology · 71d
Cleared Mar 23, 1984
ORTHO BI-LEVEL RECEPTOR CONTROL
K834064
Ortho Diagnostic Systems, Inc.
Chemistry · 119d
Cleared Jan 13, 1984
OMNI-FAL I & II
K833009
American Monitor Corp.
Chemistry · 129d
Cleared Jan 04, 1984
TITANGEL HIGH RESOLUTION CONTROL
K833639
Helena Laboratories
Chemistry · 79d
Cleared Dec 08, 1983
VENTREZYME EIA CONTROLS-IMMUNOASSAY
K833423
Ventrex Laboratories, Inc.
Immunology · 66d
Cleared Jul 07, 1983
ELECTROPHORESIS CONTROLS-3 IN 1
K831263
Corning Medical & Scientific
Chemistry · 80d
Cleared Feb 07, 1983
IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS
K823352
American Dade
Chemistry · 90d
Cleared Jan 28, 1983
MULTIANALYTE CONTROLS-ALL KINDS
K823929
Fisher Scientific Co., LLC
Chemistry · 30d
Cleared Jan 05, 1983
ORTHO BI-LEVEL ASSAYED LIPID PROFILE
K823490
Ortho Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Oct 27, 1982
MONI-TRO ES CHEMISTRY CONTROL LEVEL IX
K822850
American Dade
Chemistry · 34d
Cleared Aug 16, 1982
TITAN GEL SERUM CONTROL
K821982
Helena Laboratories
Chemistry · 41d
Cleared Aug 10, 1982
BI-LEVEL ASSAYED TUMOR MARKER & ANTIN
K821026
Ortho Diagnostic Systems, Inc.
Chemistry · 119d
Cleared Aug 03, 1982
IGE/THE OPHYLLINE CONTROL SERUM I,II,III
K822133
Kallestad Laboratories, Inc.
Chemistry · 14d
Cleared May 28, 1982
CHEMISTRY CONTROL/STANDARD
K821382
Medical Analysis Systems, Inc.
Chemistry · 18d
Cleared May 21, 1982
RESPONSE LIQUID LIGAND ASSAY SERUM
K821242
Beckman Instruments, Inc.
Chemistry · 22d
Cleared Feb 18, 1982
BI-LEVEL ASSAYED URINE METAL CONTROL
K820255
Ortho Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Jan 18, 1982
Q-LINE LTC
K813580
Miles Laboratories, Inc.
Chemistry · 25d
Cleared Dec 17, 1981
ORTHO CO2 DILUENT LEVEL I
K813293
Ortho Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Dec 17, 1981
ORTHO CO2 DILUENT LEVEL II
K813294
Ortho Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Dec 17, 1981
ORTHO CO2 DILUENT LEVEL III
K813295
Ortho Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Dec 17, 1981
ORTHO* UNASSAYED CONTROL SERUM LEVEL I
K813321
Ortho Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Dec 17, 1981
ORTHO* UNASSAYED CONTROL SERUM LEVEL III
K813322
Ortho Diagnostic Systems, Inc.
Chemistry · 23d