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
241–264 of 673
Cleared Jan 28, 1999
ABBOTT LIQUID CSF CONTROL, MODEL #'S 1E98-01, 1E99-01
K990161
Bio-Rad
Chemistry · 9d
Cleared Jan 26, 1999
ABBOTT LIQUID PEDIATRIC CHEMISTRY CONTROL, MODEL # 4E37-01, 4E38-01
K990149
Bio-Rad
Chemistry · 7d
Cleared Jan 26, 1999
ABBOTT LIQUID LIPIDS CHEMISTRY, MODEL #'S 3E18-01, 3E19-01
K990150
Bio-Rad
Chemistry · 7d
Cleared Jan 25, 1999
ABBOTT IMMUNOASSAY-MCC (LIQUID) CONTROL, MODEL NUMBER 6E20-10
K990017
Bio-Rad
Chemistry · 21d
Cleared Dec 17, 1998
ARCHITECT FERRITIN MASTERCHECK, MODEL NUMBER 6C11-05
K984325
Bio-Rad
Immunology · 14d
Cleared Dec 16, 1998
LYPHOCHEK TUMOR MARKER CONTROL, MODEL #580
K983807
Bio-Rad
Immunology · 49d
Cleared Dec 14, 1998
LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384
K984225
Bio-Rad
Chemistry · 19d
Cleared Dec 14, 1998
ELECSYS CALCHECK TROPONIN T
K984372
Boehringer Mannheim Corp.
Chemistry · 7d
Cleared Nov 20, 1998
ARCHITECT TOTAL T4 MASTERCHECK, LIST NO. 6C49-05
K984074
Bio-Rad
Chemistry · 4d
Cleared Nov 04, 1998
VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY
K983507
Ortho-Clinical Diagnostics, Inc.
Chemistry · 28d
Cleared Nov 03, 1998
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
K983513
Ortho-Clinical Diagnostics, Inc.
Chemistry · 27d
Cleared Oct 09, 1998
BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC
K983492
Boehringer Mannheim Corp.
Chemistry · 4d
Cleared Sep 29, 1998
LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS
K983130
Kamiya Biomedical Co.
Immunology · 21d
Cleared Sep 29, 1998
ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS
K983241
Kamiya Biomedical Co.
Immunology · 14d
Cleared Sep 22, 1998
ELECSYS CALCHECK MYOGLOBIN
K983166
Boehringer Mannheim Corp.
Chemistry · 12d
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 22, 1998
CHEM-CHEX STAT (NEW)
K982290
Streck Laboratories, Inc.
Chemistry · 23d
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 May 07, 1998
CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)
K981474
Spectral Diagnostics, Inc.
Chemistry · 13d
Cleared Apr 21, 1998
QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3
K981339
Consolidated Technologies, Inc.
Chemistry · 8d