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
73–96 of 493
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
Cleared Aug 27, 1996
ELECYS CALCHECK T 3
K963167
Boehringer Mannheim Corp.
Chemistry · 13d
Cleared Aug 27, 1996
ELECSYS CALCHECK T4
K963178
Boehringer Mannheim Corp.
Chemistry · 13d
Cleared Aug 23, 1996
ELECSYS CALCHECK TROPONIN T
K963143
Boehringer Mannheim Corp.
Chemistry · 10d
Cleared Aug 23, 1996
ELECSYS CALCHECK TSH
K963147
Boehringer Mannheim Corp.
Chemistry · 10d
Cleared Aug 23, 1996
ELECSYS CALCHECK CK-MB
K963182
Boehringer Mannheim Corp.
Chemistry · 9d
Cleared Jul 22, 1996
ELECSYS PRECICONTROL TSH
K962573
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Mar 13, 1996
PSA CONTROLS
K960154
Diagnostic Products Corp.
Immunology · 57d
Cleared Sep 08, 1995
IMMULITE HCG HIGH LEVEL CONTROL MODULE
K952251
Diagnostic Products Corp.
Chemistry · 116d
Cleared Apr 03, 1995
IMMULITE(R) TBG
K950072
Diagnostic Products Corp.
Chemistry · 84d
Cleared Mar 30, 1995
REP CHOLESTEROL PROFILE CONTROL
K950590
Helena Laboratories
Chemistry · 49d
Cleared Nov 22, 1994
QUANTITATE URIC ACID VERIFIER SET
K944453
Beckman Instruments, Inc.
Chemistry · 71d
Cleared Jun 21, 1994
AXSYM LUTEINIZING HORMONE (LH)
K935611
Abbott Laboratories
Chemistry · 211d
Cleared Aug 16, 1993
IMMULITE TSH THIRD GENERATION CONTROL
K930007
Diagnostic Products Corp.
Chemistry · 224d
Cleared Feb 05, 1993
KODAK AMERLITE CK-MB CONTROL SERA LAN.4413
K925880
Eastman Kodak Company
Chemistry · 78d
Cleared Apr 29, 1992
LYPHOCHEK(R) FRUCTOSAMINE CONTROL
K921089
Bio-Rad
Chemistry · 54d
Cleared Jan 30, 1992
MILENIA DATA REDUCTION
K915806
Diagnostic Products Corp.
Chemistry · 37d
Cleared Oct 15, 1990
DUPONT DRUG CALIBRATOR-A
K904306
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 26d
Cleared Aug 09, 1990
PRECINORM HDL CHOLESTEROL CONTROL MATERIAL FOR REF
K902569
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared May 30, 1990
ROTAG CONTROLS
K900719
Roche Diagnostic Systems, Inc.
Chemistry · 105d