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
217–240 of 673
Cleared Nov 24, 1999
ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK
K992710
Abbott Laboratories
Immunology · 105d
Cleared Nov 24, 1999
PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA
K992900
Roche Diagnostics Corp.
Immunology · 86d
Cleared Nov 24, 1999
PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
K993360
Roche Diagnostics Corp.
Immunology · 49d
Cleared Nov 12, 1999
QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3
K992770
Seracare Technology
Immunology · 87d
Cleared Nov 09, 1999
LYPHOCHEK ANEMIA CONTROL, MODEL 500
K992741
Bio-Rad
Immunology · 85d
Cleared Sep 02, 1999
LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580
K992172
Bio-Rad
Chemistry · 66d
Cleared Aug 24, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS
K992349
Ortho-Clinical Diagnostics, Inc.
Chemistry · 41d
Cleared Aug 11, 1999
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3
K992550
Bio-Rad
Chemistry · 12d
Cleared Jul 23, 1999
DOCUMENT THYROID CAL*VER
K992034
Casco-Nerl Diagnostics Corporation (Maine)
Chemistry · 37d
Cleared Jun 25, 1999
N/T PROTEIN CONTROL LC
K991704
Dade Behring, Inc.
Chemistry · 37d
Cleared Jun 11, 1999
CARDIOQUANT CARDIAC ASSESSMENT CONTROLS
K991447
Spectral Diagnostics, Inc.
Chemistry · 46d
Cleared May 19, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS
K990016
Ortho-Clinical Diagnostics, Inc.
Immunology · 135d
Cleared May 19, 1999
MODIFICATION OF N/T PROTEIN CONTROL SL
K991182
Dade Behring, Inc.
Chemistry · 42d
Cleared Apr 27, 1999
ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10
K990610
Bio-Rad
Chemistry · 62d
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