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 Beckman Instruments, Inc..

37
Total
37
Cleared
107d
Avg days
1977
Since
37 devices
25–37 of 37
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
Cleared Oct 13, 1987
ALBUMIN IN URINE
K873861
Unipath , Ltd.
Immunology · 50d
Cleared Sep 18, 1986
MICROALBUMINURIA ASSAY
K862671
Orion Corp.
Immunology · 66d
Cleared Jun 17, 1985
RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI
K851285
Cooper Biomedical, Inc.
Immunology · 77d
Cleared Sep 23, 1981
IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALBUM
K812496
Dako Corp.
Immunology · 23d
Cleared Oct 23, 1980
ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE
K802404
Ortho Diagnostics, Inc.
Immunology · 17d
Cleared Jun 22, 1978
ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM
K780913
Beckman Instruments, Inc.
Immunology · 17d
Cleared Oct 07, 1977
QUAN. COLOR. DETER. OF SERUM ALBUMIN
K771771
Stanbio Laboratory
Immunology · 18d
Cleared Apr 07, 1977
LOW LEVEL HUMAN ALBUMIN TEST KITS
K761225
Intl. Diagnostic Technology
Immunology · 120d