JJX · Class I · 21 CFR 862.1660

FDA Product Code JJX: Single (specified) Analyte Controls (assayed And Unassayed)

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

493
Total
493
Cleared
62d
Avg days
1976
Since
493 devices
49–72 of 493
Cleared Nov 25, 1998
ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05
K984073
Bio-Rad
Chemistry · 9d
Cleared Nov 24, 1998
ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05
K984072
Bio-Rad
Chemistry · 8d
Cleared Nov 18, 1998
CARDIAC MARKER CONTROL MODULE, MODEL CCCM
K983971
Diagnostic Products Corp.
Chemistry · 9d
Cleared Nov 12, 1998
ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05
K983578
Bio-Rad
Chemistry · 30d
Cleared Aug 06, 1998
B2-MICROGLOBULIN CONTROL SET SERUM
K982471
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Aug 05, 1998
DADE TRU-LIQUID CARDIAC CONTROL
K982591
Dade Behring, Inc.
Chemistry · 12d
Cleared Jul 06, 1998
VIGIL HEMOGLOBIN (HBALC) CONTROLS
K982022
Beckman Coulter, Inc.
Hematology · 27d
Cleared Jun 12, 1998
ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219
K981864
Beckman Coulter, Inc.
Chemistry · 16d
Cleared Jun 08, 1998
DADE TRU-LIQUID CARDIAC CONTROL
K981622
Dade Behring, Inc.
Chemistry · 32d
Cleared Jan 06, 1998
REP CHOLESTEROL PROFILE CONTROL-II
K974609
Helena Laboratories
Chemistry · 27d
Cleared Dec 08, 1997
ELECSYS CALCHECK VITAMIN B12
K974383
Boehringer Mannheim Corp.
Chemistry · 17d
Cleared Oct 06, 1997
MYOGLOBIN CONTROL SET
K973358
Boehringer Mannheim Corp.
Chemistry · 28d
Cleared Aug 06, 1997
ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P
K972721
Roche Diagnostic Systems, Inc.
Chemistry · 16d
Cleared Apr 10, 1997
IMMULITE THYROID AUTOANTIBODY CONTROL MODULE
K971051
Diagnostic Products Corp.
Immunology · 17d
Cleared Apr 02, 1997
THE ELECSYS CALCHECK PROGESTERONE
K970984
Boehringer Mannheim Corp.
Chemistry · 16d
Cleared Mar 06, 1997
ELECSYS CALCHECK CEA
K970452
Boehringer Mannheim Corp.
Immunology · 28d
Cleared Mar 06, 1997
ELECSYS CALCHECK PSA
K970458
Boehringer Mannheim Corp.
Immunology · 28d
Cleared Mar 06, 1997
ELECSYS CALCHECK CEA
K970459
Boehringer Mannheim Corp.
Immunology · 28d
Cleared Mar 03, 1997
ABBOTT HCG SERUM CONTROLS
K970527
Abbott Laboratories
Chemistry · 20d
Cleared Feb 10, 1997
ELECSYS CALCHECK ESTRADIOL
K970148
Boehringer Mannheim Corp.
Chemistry · 26d
Cleared Jan 30, 1997
ELECSYS CALCHECK TESTOSTERONE
K970146
Boehringer Mannheim Corp.
Chemistry · 15d
Cleared Dec 16, 1996
ELECSYS CALCHECK LH
K964830
Boehringer Mannheim Corp.
Chemistry · 14d
Cleared Oct 28, 1996
RADIAS GALT TEST
K961432
Bio-Rad
Chemistry · 196d
Cleared Sep 10, 1996
ELECSYS CALCHECK T UPDATE
K963181
Boehringer Mannheim Corp.
Chemistry · 27d