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
265–288 of 493
Cleared Jul 07, 1997
DADE TRU-LIQUID BILIRUBIN CONTROL
K972287
Dade Intl., Inc.
Chemistry · 18d
Cleared Apr 23, 1997
LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS
K971014
Lifescan, Inc.
Chemistry · 34d
Cleared Apr 17, 1997
LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4
K970778
More Diagnostics
Chemistry · 44d
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 Feb 06, 1997
HCG CONTROLS
K970176
International Newtech Development, Inc.
Chemistry · 20d
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 Nov 22, 1996
WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6
K964278
Clinical Controls, Inc.
Chemistry · 25d
Cleared Nov 08, 1996
HEMOCUE GLUCOLIN
K963909
Direct Solutions
Chemistry · 39d
Cleared Nov 01, 1996
HEMOCUE GLUCOTROL
K964053
Direct Solutions
Chemistry · 32d
Cleared Oct 28, 1996
RADIAS GALT TEST
K961432
Bio-Rad
Chemistry · 196d
Cleared Oct 07, 1996
BIO-CSF LIQUID CONTROL LEVEL 1 AND 2
K963551
Biocell Laboratories, Inc.
Chemistry · 32d
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
Cleared Aug 27, 1996
ELECSYS CALCHECK FT4
K963164
Boehringer Mannheim Corp.
Chemistry · 13d