DFC · Class II · 21 CFR 866.5600

FDA Product Code DFC: Lipoprotein, Low-density, Antigen, Antiserum, Control

Leading manufacturers include Wako Chemicals USA, Inc., DiaSorin, Inc. and Roche Diagnostics Corp..

43
Total
43
Cleared
107d
Avg days
1977
Since
43 devices
25–43 of 43
Cleared Apr 14, 1999
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B
K990595
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Apr 02, 1999
SPQ TEST SYSTEM
K982708
DiaSorin, Inc.
Chemistry · 241d
Cleared Mar 09, 1999
WAKO AUTOKIT LP(A)
K981446
Wako Chemicals USA, Inc.
Chemistry · 321d
Cleared Jan 26, 1999
APOB
K983281
Abbott Laboratories
Immunology · 130d
Cleared Oct 01, 1998
IMX HOMOCYSTEINE
K980812
Axis Biochemicals, Asa
Chemistry · 212d
Cleared Nov 10, 1997
APO-TEK LP(A)
K970302
Perimmune, Inc.
Immunology · 287d
Cleared Dec 20, 1995
WAKO AUTOKIT APO B
K954657
Wako Chemicals USA, Inc.
Immunology · 71d
Cleared Feb 05, 1993
IL TEST CALIBRATION SET APO A1B
K923079
Instrumentation Laboratory CO
Immunology · 225d
Cleared Aug 02, 1990
EQUATE(TM) AQR APO AL/B DUO CONTROL
K903122
Binax, Inc.
Immunology · 17d
Cleared Sep 22, 1988
QM300 CALIBRATOR F PACK
K883711
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 23d
Cleared Sep 22, 1988
QM300 CONTROL F PACK
K883712
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 23d
Cleared Jun 15, 1987
RAICHEM(TM) SPIA(TM) APO B REAGENTS
K872080
Reagents Applications, Inc.
Immunology · 17d
Cleared Aug 14, 1978
ANTI-HUMAN LDL SERUM
K781015
Icl Scientific
Immunology · 59d
Cleared Oct 19, 1977
LAS-R BETA LIPOPROTEIN TEST
K771912
Hyland Therapeutic Div., Travenol Laboratories
Immunology · 8d