DEH · Class II · 21 CFR 866.5550

FDA Product Code DEH: Lambda, Antigen, Antiserum, Control

Leading manufacturers include Ventana Medical Systems, Inc., Dako Corp. and The Binding Site, Ltd..

53
Total
53
Cleared
406d
Avg days
1977
Since
53 devices
25–48 of 53
Cleared Mar 22, 1996
ANTI-KERATIN-HMW PRIMARY ANTI-BODY
K941173
Ventana Medical Systems, Inc.
Immunology · 739d
Cleared Feb 26, 1996
KERATIN PRIMARY ANTIBODY
K940331
Ventana Medical Systems, Inc.
Immunology · 763d
Cleared Nov 06, 1995
VENTANA BLUE DETECTION KIT
K940424
Ventana Medical Systems, Inc.
Immunology · 644d
Cleared Apr 20, 1995
DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODY
K931192
Dako Corp.
Immunology · 772d
Cleared Nov 21, 1994
DAKO MOUSE ANTI-HUMAN T-CELL
K924804
Dako Corp.
Immunology · 788d
Cleared Jun 13, 1994
DAKO MOUSE ANTI-HUMAN B-CELL (DAKO-C020-L26 MONO ANTI
K924726
Dako Corp.
Immunology · 630d
Cleared Jun 13, 1994
DAKO MOUSE ANTI-HUMAN MELANOMA (DAKO ANTI-HMB45)
K932136
Dako Corp.
Immunology · 406d
Cleared Aug 06, 1993
PSA ANTIBODY KIT
K932326
Ventana Medical Systems, Inc.
Immunology · 100d
Cleared Aug 27, 1990
MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT
K896918
Dako Corp.
Hematology · 259d
Cleared Jun 21, 1990
BECKMAN LAMBDA LIGHT CHAIN REAGENT (ADD'L CLAIMS)
K902485
Beckman Instruments, Inc.
Immunology · 16d
Cleared Jan 22, 1988
QM300 LAMBDA LIGHT CHAINS ANTIBODY PACK
K875165
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 37d
Cleared Feb 26, 1986
QUANTIMETRIC PLUS LAMBDA REAGENT KIT
K855007
Kallestad Laboratories, Inc.
Immunology · 72d
Cleared Feb 26, 1986
QUANTIMETRIC PLUS SUPPORT PACK
K855013
Kallestad Laboratories, Inc.
Immunology · 72d
Cleared Oct 21, 1985
QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT
K852999
Kallestad Laboratories, Inc.
Immunology · 98d
Cleared Aug 03, 1984
AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN
K842328
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 51d
Cleared Jul 11, 1984
QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT
K841864
Kallestad Laboratories, Inc.
Immunology · 68d
Cleared Sep 29, 1981
IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDA
K812662
Dako Corp.
Immunology · 11d
Cleared Jul 27, 1978
LAMBDA SERUM (FREE) ANTI-HUMAN
K781025
Icl Scientific
Immunology · 38d
Cleared Jul 27, 1978
ANTI-HUMAN LAMBDA SERUM
K781220
Icl Scientific
Immunology · 10d
Cleared Oct 07, 1977
GOAT LAMBDA-LIGHT CHAIN ANTI-HUMAN SERUM
K771768
G.D. Searle and Co.
Immunology · 18d