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
289–312 of 493
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 Aug 20, 1996
LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III
K963085
International Enzymes, Inc.
Chemistry · 12d
Cleared Aug 15, 1996
OPUS MYOGLOBIN CONTROLS
K962841
Behring Diagnostics, Inc.
Immunology · 24d
Cleared Jul 22, 1996
ELECSYS PRECICONTROL TSH
K962573
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Jul 22, 1996
OPUS B12 CONTROLS
K962694
Behring Diagnostics, Inc.
Chemistry · 11d
Cleared Jul 05, 1996
LIQUISPEX URINE (MICRO)ALBUMIN CONTROL
K962432
Clinical Controls, Inc.
Chemistry · 11d
Cleared Jun 17, 1996
ACS FRT4 IMMUNOASSAY
K961510
Ciba Corning Diagnostics Corp.
Chemistry · 59d
Cleared Jun 14, 1996
COMPLEMENT CONTROL
K960874
Wako Chemicals USA, Inc.
Immunology · 102d
Cleared Apr 23, 1996
OPUS T3 CONTROLS
K961206
Behring Diagnostics, Inc.
Chemistry · 27d
Cleared Apr 03, 1996
ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS
K960378
Actimed Laboratories, Inc.
Chemistry · 68d
Cleared Mar 20, 1996
LXN FRUCTOSAMINE TEST
K955629
Lxn Corp.
Chemistry · 100d
Cleared Mar 13, 1996
PSA CONTROLS
K960154
Diagnostic Products Corp.
Immunology · 57d
Cleared Feb 29, 1996
IRON CALIBRATOR & CALIBRATION VERIFICATION SET
K955796
Data Medical Associates, Inc.
Chemistry · 69d
Cleared Feb 23, 1996
OPUS PROLACTIN CONTROLS
K955468
Behring Diagnostics, Inc.
Chemistry · 85d
Cleared Nov 14, 1995
ACCESS LOW LEVEL IGE CONTROLS
K953883
Bio-Rad Laboratories, Inc.
Immunology · 88d
Cleared Oct 06, 1995
OPUS HCG CONTROLS
K954144
Behring Diagnostics, Inc.
Chemistry · 31d
Cleared Sep 08, 1995
IMMULITE HCG HIGH LEVEL CONTROL MODULE
K952251
Diagnostic Products Corp.
Chemistry · 116d
Cleared Aug 24, 1995
OPUS T4 CONTROLS
K953097
Behring Diagnostics, Inc.
Chemistry · 52d
Cleared Jul 13, 1995
DADE STRATUS TROPONIN-I CONTROL
K951888
Dade Intl., Inc.
Chemistry · 80d
Cleared Jun 06, 1995
SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3
K944999
More Diagnostics
Chemistry · 236d