Panels › Immunology › Product code DEH · Class 2
Lambda, Antigen, Antiserum, Control
Regulation 866.5550
0510(k)s in 12 months (53 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in DEH
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 8, 2018 | K172471 | VENTANA CD30 (Ber-H2) RxDx Assay Ventana Medical Systems, Inc. | DEH |
| Apr 16, 2014 | K140396 | FREELITE HUMAN LAMBDA FREE KIT The Binding Site Group , Ltd. | DEH |
| Jun 22, 2009 | K083601 | LAMBDA LIGHT CHAINS SENTINEL CH. SpA, IT | DEH |
| Jan 30, 2004 | K033811 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER The Binding Site, Ltd. | DEH |
| Jul 15, 2003 | K031016 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II The Binding Site, Ltd. | DEH |
| Jan 21, 2003 | K023131 | FREELITE HUMAN LAMBDA FREE KIT The Binding Site, Ltd. | DEH |
| Apr 26, 2001 | K010441 | FREELITE KAPPA FREE KIT The Binding Site, Ltd. | DEH |
| Apr 26, 2001 | K010440 | FREELITE LAMBDA FREE KIT The Binding Site, Ltd. | DEH |
| Feb 1, 2001 | K003671 | LAMBDA IMMAGE FREELITE KIT The Binding Site, Ltd. | DEH |
| Oct 26, 2000 | K002563 | SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT The Binding Site, Ltd. | DEH |
| Dec 12, 1997 | K971905 | DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING Dako Corp. | DEH |
| Nov 6, 1997 | K965022 | MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751) Dako Corp. | DEH |
| Oct 20, 1997 | K940583 | VENTANA CD45 PRIMARY ANTIBODY Ventana Medical Systems, Inc. | DEH |
| Sep 25, 1997 | K973393 | CHEMMATE LCA Ventana Medical Systems, Inc. | DEH |
| Apr 25, 1997 | K941514 | VENTANA ANTI-S100 PRIMARY ANTIBODY Ventana Medical Systems, Inc. | DEH |
| Apr 22, 1997 | K941170 | VENTANA ANTI-MELANOMA PRIMARY ANTIBODY Ventana Medical Systems, Inc. | DEH |
| Apr 21, 1997 | K941707 | ANTI-MUSCLE ACTIN PRIMARY ANTIBODY Ventana Medical Systems, Inc. | DEH |
| Feb 14, 1997 | K941784 | VENTANA ANTI-CD8 PRIMARY ANTIBODY Ventana Medical Systems, Inc. | DEH |
| Feb 14, 1997 | K941604 | VENTANA ANTI-CD4 PRIMARY ANTIBODY Ventana Medical Systems, Inc. | DEH |
| Feb 10, 1997 | K941516 | VENTANNA ANTI-DESMIN PRIMARY ANTIBODY Ventana Medical Systems, Inc. | DEH |
| Feb 10, 1997 | K941397 | ANTI-VIMENTIN PRIMARY ANTIBODY Ventana Medical Systems, Inc. | DEH |
| Sep 10, 1996 | K941782 | VENTANA ANTI-CD5 PRIMARY ANTIBODY Ventana Medical Systems, Inc. | DEH |
| Jul 5, 1996 | K951965 | DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION Dako Corp. | DEH |
| Jul 2, 1996 | K950148 | CHEMMATE(TM) CD43 Biotek Solutions, Inc. | DEH |
| May 30, 1996 | K941505 | VENTANNA ANTI-CD3 PRIMARY ANTIBODY Ventana Medical Systems, Inc. | DEH |
| Mar 22, 1996 | K941173 | ANTI-KERATIN-HMW PRIMARY ANTI-BODY Ventana Medical Systems, Inc. | DEH |
| Mar 22, 1996 | K935161 | KERATIN PRIMARY ANTIBODY Ventana Medical Systems, Inc. | DEH |
| Feb 27, 1996 | K936111 | CHEMMATE SPECIAL STAIN LCA-CD45 Biotek Solutions, Inc. | DEH |
| Feb 26, 1996 | K940331 | KERATIN PRIMARY ANTIBODY Ventana Medical Systems, Inc. | DEH |
| Dec 6, 1995 | K950149 | CHEMMATE(TM) LAMBDA Biotek Solutions, Inc. | DEH |
| Nov 6, 1995 | K940424 | VENTANA BLUE DETECTION KIT Ventana Medical Systems, Inc. | DEH |
| Oct 4, 1995 | K950151 | CHEMMATE(TM) L26 (CD20) Biotek Solutions, Inc. | DEH |
| Apr 20, 1995 | K931192 | DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODY Dako Corp. | DEH |
| Nov 21, 1994 | K924804 | DAKO MOUSE ANTI-HUMAN T-CELL Dako Corp. | DEH |
| Jun 13, 1994 | K932136 | DAKO MOUSE ANTI-HUMAN MELANOMA (DAKO ANTI-HMB45) Dako Corp. | DEH |
| Jun 13, 1994 | K924726 | DAKO MOUSE ANTI-HUMAN B-CELL (DAKO-C020-L26 MONO ANTI Dako Corp. | DEH |
| Aug 6, 1993 | K932326 | PSA ANTIBODY KIT Ventana Medical Systems, Inc. | DEH |
| Aug 27, 1990 | K896918 | MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT Dako Corp. | DEH |
| Jun 21, 1990 | K902485 | BECKMAN LAMBDA LIGHT CHAIN REAGENT (ADD'L CLAIMS) Beckman Instruments, Inc. | DEH |
| Jan 22, 1988 | K875165 | QM300 LAMBDA LIGHT CHAINS ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | DEH |
| Feb 26, 1986 | K855013 | QUANTIMETRIC PLUS SUPPORT PACK Kallestad Laboratories, Inc. | DEH |
| Feb 26, 1986 | K855007 | QUANTIMETRIC PLUS LAMBDA REAGENT KIT Kallestad Laboratories, Inc. | DEH |
| Oct 21, 1985 | K852999 | QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT Kallestad Laboratories, Inc. | DEH |
| Aug 3, 1984 | K842328 | AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN Bartels Immunodiagnostic Supplies, Inc. | DEH |
| Jul 11, 1984 | K841864 | QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT Kallestad Laboratories, Inc. | DEH |
| Oct 31, 1983 | K832270 | GOAT ANTI-HUMAN LAMBA Gelco Diagnostics, Inc. | DEH |
| Oct 28, 1983 | K832261 | GOAT ANTI-HUMAN LAMBA AFFINITY Gelco Diagnostics, Inc. | DEH |
| Sep 29, 1981 | K812662 | IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDA Dako Corp. | DEH |
| Nov 27, 1979 | K791283 | ANTI-HUMAN LAMBDA SERUM Diagnostica, Inc. | DEH |
| Aug 3, 1979 | K791115 | GOAR ANTI-HUMAN LAMBODA CHAIN Protos Laboratories | DEH |
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