JJY · Class I · 21 CFR 862.1660

FDA Product Code JJY: Multi-analyte Controls, All Kinds (assayed)

Leading manufacturers include Bio-Rad, Boehringer Mannheim Corp. and Roche Diagnostics Corp..

673
Total
673
Cleared
64d
Avg days
1976
Since
673 devices
49–72 of 673
Cleared Aug 11, 1999
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3
K992550
Bio-Rad
Chemistry · 12d
Cleared Jun 25, 1999
N/T PROTEIN CONTROL LC
K991704
Dade Behring, Inc.
Chemistry · 37d
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 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 Oct 09, 1998
BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC
K983492
Boehringer Mannheim Corp.
Chemistry · 4d
Cleared Sep 22, 1998
ELECSYS CALCHECK MYOGLOBIN
K983166
Boehringer Mannheim Corp.
Chemistry · 12d