DCF · Class II · 21 CFR 866.5040

FDA Product Code DCF: Albumin, Antigen, Antiserum, Control

Leading manufacturers include Dade Behring, Inc., Beckman Instruments, Inc. and Beckman Coulter, Inc..

37
Total
37
Cleared
107d
Avg days
1977
Since

FDA 510(k) Cleared Albumin, Antigen, Antiserum, Control Devices (Product Code DCF)

37 devices
1–24 of 37
Cleared Sep 09, 2010
COBAS 8000 MODULAR SERIES ANALYZER
K100853
Roche Diagnostics Corp.
Chemistry · 167d
Cleared Apr 08, 2009
SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100
K082251
Beckman Coulter, Inc.
Chemistry · 243d
Cleared Sep 19, 2006
DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE
K061990
Dade Behring, Inc.
Chemistry · 68d
Cleared Jan 12, 2004
DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114
K033525
Dade Behring, Inc.
Chemistry · 66d
Cleared Apr 29, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT
K964695
Beckman Instruments, Inc.
Immunology · 158d
Cleared Jul 23, 1996
COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN
K961824
Roche Diagnostic Systems, Inc.
Immunology · 74d
Cleared Jun 22, 1978
ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM
K780913
Beckman Instruments, Inc.
Immunology · 17d

About Product Code DCF - Regulatory Context