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
169–192 of 673
Cleared Apr 07, 1999
MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752
K990888
Bio-Rad
Chemistry · 28d
Cleared Mar 31, 1999
ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01
K990424
Bio-Rad
Chemistry · 48d
Cleared Mar 18, 1999
ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01
K990317
Bio-Rad
Chemistry · 48d
Cleared Mar 18, 1999
ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL MODELS #1E86-02/#1E87-02
K990394
Bio-Rad
Chemistry · 37d
Cleared Mar 15, 1999
ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL 3 MODEL #4E39-01
K990391
Bio-Rad
Chemistry · 34d
Cleared Mar 12, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS
K990531
Ortho-Clinical Diagnostics, Inc.
Chemistry · 21d
Cleared Mar 09, 1999
ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01
K990282
Bio-Rad
Chemistry · 39d
Cleared Feb 02, 1999
ELECSYS IGE CALCHECK
K984419
Boehringer Mannheim Corp.
Immunology · 54d
Cleared Feb 02, 1999
LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220
K984594
Bio-Rad
Chemistry · 36d
Cleared Jan 29, 1999
LYPHOCHEK WHOLE BLOOD METALS CONTROL LEVELS 1,2,3, MODELS 527, 528, 529
K984477
Bio-Rad
Chemistry · 44d
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