JJX · Class I · 21 CFR 862.1660

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

Leading manufacturers include Roche Diagnostics, Siemens Healthcare Diagnostics, Inc. and Boehringer Mannheim Corp..

493
Total
493
Cleared
62d
Avg days
1976
Since
493 devices
217–240 of 493
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 Nov 26, 1997
SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE)
K974108
Quidel Corp.
Chemistry · 26d
Cleared Oct 27, 1997
OPUS HLH CONTROLS
K973832
Behring Diagnostics, Inc.
Toxicology · 20d
Cleared Oct 06, 1997
MYOGLOBIN CONTROL SET
K973358
Boehringer Mannheim Corp.
Chemistry · 28d
Cleared Sep 12, 1997
WAKO NEFA LINEARITY SET
K973072
Wako Chemicals USA, Inc.
Toxicology · 25d
Cleared Aug 06, 1997
ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P
K972721
Roche Diagnostic Systems, Inc.
Chemistry · 16d
Cleared Apr 23, 1997
LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS
K971014
Lifescan, Inc.
Chemistry · 34d
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
Cleared Aug 30, 1996
ELECSYS CALCHECK HCG
K963165
Boehringer Mannheim Corp.
Chemistry · 16d
Cleared Aug 29, 1996
PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM)
K962975
Diagnostic Products Corp.
Immunology · 29d
Cleared Aug 29, 1996
IMMULITE ACTH CONTROL MODULE (LACCM)
K963240
Diagnostic Products Corp.
Chemistry · 10d
Cleared Aug 27, 1996
ELECSYS CALCHECK FT3
K963163
Boehringer Mannheim Corp.
Chemistry · 13d