Product code DEH— Immunology
ANTI-HUMAN LAMBDA SERUM
- Classification name
- Lambda, Antigen, Antiserum, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5550
- Advisory panel
- Immunology
- Total cleared
- 53
- First cleared
- Most recent
Market context for product code DEH
FDA has cleared devices under product code DEH between 1977 and 2018, filed by 15 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2018
- 2014
- 2009
- 2004
- 2003
- 2001
- 2000
- 1997
- 1996
- 1995
- 1994
- 1993
- 1990
- 1988
- 1986
Top applicants under product code DEH
Recent clearances under product code DEH
- K172471 — VENTANA CD30 (Ber-H2) RxDx Assay
- K140396 — FREELITE HUMAN LAMBDA FREE KIT
- K083601 — LAMBDA LIGHT CHAINS
- K033811 — FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER
- K031016 — FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II
- K023131 — FREELITE HUMAN LAMBDA FREE KIT
- K010440 — FREELITE LAMBDA FREE KIT
- K010441 — FREELITE KAPPA FREE KIT
- K003671 — LAMBDA IMMAGE FREELITE KIT
- K002563 — SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT
- K971905 — DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING
- K965022 — MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751)
- K940583 — VENTANA CD45 PRIMARY ANTIBODY
- K973393 — CHEMMATE LCA
- K941514 — VENTANA ANTI-S100 PRIMARY ANTIBODY
- K941170 — VENTANA ANTI-MELANOMA PRIMARY ANTIBODY
- K941707 — ANTI-MUSCLE ACTIN PRIMARY ANTIBODY
- K941604 — VENTANA ANTI-CD4 PRIMARY ANTIBODY
- K941784 — VENTANA ANTI-CD8 PRIMARY ANTIBODY
- K941397 — ANTI-VIMENTIN PRIMARY ANTIBODY
- K941516 — VENTANNA ANTI-DESMIN PRIMARY ANTIBODY
- K941782 — VENTANA ANTI-CD5 PRIMARY ANTIBODY
- K951965 — DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION
- K950148 — CHEMMATE(TM) CD43
- K941505 — VENTANNA ANTI-CD3 PRIMARY ANTIBODY
- K935161 — KERATIN PRIMARY ANTIBODY
- K941173 — ANTI-KERATIN-HMW PRIMARY ANTI-BODY
- K936111 — CHEMMATE SPECIAL STAIN LCA-CD45
- K940331 — KERATIN PRIMARY ANTIBODY
- K950149 — CHEMMATE(TM) LAMBDA
- K940424 — VENTANA BLUE DETECTION KIT
- K950151 — CHEMMATE(TM) L26 (CD20)
- K931192 — DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODY
- K924804 — DAKO MOUSE ANTI-HUMAN T-CELL
- K924726 — DAKO MOUSE ANTI-HUMAN B-CELL (DAKO-C020-L26 MONO ANTI
- K932136 — DAKO MOUSE ANTI-HUMAN MELANOMA (DAKO ANTI-HMB45)
- K932326 — PSA ANTIBODY KIT
- K896918 — MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT
- K902485 — BECKMAN LAMBDA LIGHT CHAIN REAGENT (ADD'L CLAIMS)
- K875165 — QM300 LAMBDA LIGHT CHAINS ANTIBODY PACK
- K855007 — QUANTIMETRIC PLUS LAMBDA REAGENT KIT
- K855013 — QUANTIMETRIC PLUS SUPPORT PACK
- K852999 — QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT
- K842328 — AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN
- K841864 — QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT
- K832270 — GOAT ANTI-HUMAN LAMBA
- K832261 — GOAT ANTI-HUMAN LAMBA AFFINITY
- K812662 — IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDA
- K791283 — ANTI-HUMAN LAMBDA SERUM
- K791115 — GOAR ANTI-HUMAN LAMBODA CHAIN
- K781025 — LAMBDA SERUM (FREE) ANTI-HUMAN
- K781220 — ANTI-HUMAN LAMBDA SERUM
- K771768 — GOAT LAMBDA-LIGHT CHAIN ANTI-HUMAN SERUM
Data sourced from openFDA. This site is unofficial and independent of the FDA.