DCF · Class II · 21 CFR 866.5040

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

Leading manufacturers include Kallestad Diag, A Div. of Erbamont, Inc., The Binding Site Group , Ltd. and Technicon Instruments Corp..

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 Aug 25, 2016
Optilite Low Level Albumin Kit
K153560
The Binding Site Group , Ltd.
Immunology · 255d
Cleared May 26, 2015
Human Microalbumin kit for use on SPAPLUS
K143118
The Binding Site Group , Ltd.
Chemistry · 208d
Cleared Jun 19, 2013
HUMAN ALBUMIN CSF KIT
K121045
The Binding Site Group , Ltd.
Immunology · 439d
Cleared Jul 13, 2011
EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR
K101089
Medica Corp.
Chemistry · 450d
Cleared Sep 10, 2010
TINA-QUANT ALBUMIN GEN 2
K101203
Roche Diagnostics
Chemistry · 134d
Cleared Sep 09, 2010
COBAS 8000 MODULAR SERIES ANALYZER
K100853
Roche Diagnostics Corp.
Chemistry · 167d
Cleared Apr 29, 2010
K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR
K091486
Kamiya Biomedical Co.
Chemistry · 345d
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 Jul 05, 2005
DCL MICROALBUMIN ASSAY, MODEL 252-20
K051191
Diagnostic Chemicals , Ltd.
Chemistry · 56d
Cleared Nov 18, 2004
VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II
K042643
Ortho-Clinical Diagnostics, Inc.
Chemistry · 52d
Cleared Jan 12, 2004
DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114
K033525
Dade Behring, Inc.
Chemistry · 66d
Cleared Oct 20, 1997
N ANTISERUM TO HUMAN ALBUMIN
K972929
Behring Diagnostics, Inc.
Immunology · 73d
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 Dec 10, 1991
ALBUMIN TEST RID KIT
K914391
The Binding Site, Ltd.
Immunology · 70d
Cleared Jan 22, 1990
TURBIQUANT IMMUNOGLOBULIN & ALBUMIN KIT
K900167
Behring Diagnostics, Inc.
Immunology · 10d
Cleared Nov 06, 1989
MODIFIED QM300 ALBUMIN ANTIBODY PACK
K896059
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 19d
Cleared Oct 17, 1989
TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN
K895808
Technicon Instruments Corp.
Immunology · 15d
Cleared Aug 04, 1988
TECHNICON DPA-1(TM) SYSTEM
K882153
Technicon Instruments Corp.
Immunology · 73d
Cleared Jul 08, 1988
QM300 ALBUMIN ANTIBODY PACK
K882082
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 51d
Cleared Apr 21, 1988
QM300 CALIBRATOR D PACK
K881127
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 36d
Cleared Apr 06, 1988
QM300 ALBUMIN ANTIBODY PACK
K881126
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 21d
Cleared Oct 20, 1987
ALBUMIN IN SERUM
K873862
Unipath , Ltd.
Immunology · 57d

About Product Code DCF - Regulatory Context