FDA Product Code
FDA Product Code DEH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5550
510(k) Clearances — 53 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K172471 | VENTANA CD30 (Ber-H2) RxDx Assay | Ventana Medical Systems, Inc. | 2018-05-08 | Traditional | PDF ↗ |
| K140396 | FREELITE HUMAN LAMBDA FREE KIT | The Binding Site Group , Ltd. | 2014-04-16 | Traditional | PDF ↗ |
| K083601 | LAMBDA LIGHT CHAINS | SENTINEL CH. SpA | 2009-06-22 | Traditional | PDF ↗ |
| K033811 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER | The Binding Site, Ltd. | 2004-01-30 | Traditional | PDF ↗ |
| K031016 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II | The Binding Site, Ltd. | 2003-07-15 | Traditional | PDF ↗ |
| K023131 | FREELITE HUMAN LAMBDA FREE KIT | The Binding Site, Ltd. | 2003-01-21 | Traditional | PDF ↗ |
| K010440 | FREELITE LAMBDA FREE KIT | The Binding Site, Ltd. | 2001-04-26 | Traditional | PDF ↗ |
| K010441 | FREELITE KAPPA FREE KIT | The Binding Site, Ltd. | 2001-04-26 | Traditional | PDF ↗ |
| K003671 | LAMBDA IMMAGE FREELITE KIT | The Binding Site, Ltd. | 2001-02-01 | Traditional | PDF ↗ |
| K002563 | SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT | The Binding Site, Ltd. | 2000-10-26 | Traditional | PDF ↗ |
| K971905 | DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING | Dako Corp. | 1997-12-12 | Traditional | PDF ↗ |
| K965022 | MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751) | Dako Corp. | 1997-11-06 | Traditional | PDF ↗ |
| K940583 | VENTANA CD45 PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-10-20 | Traditional | PDF ↗ |
| K973393 | CHEMMATE LCA | Ventana Medical Systems, Inc. | 1997-09-25 | Traditional | PDF ↗ |
| K941514 | VENTANA ANTI-S100 PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-04-25 | Traditional | PDF ↗ |
| K941170 | VENTANA ANTI-MELANOMA PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-04-22 | Traditional | PDF ↗ |
| K941707 | ANTI-MUSCLE ACTIN PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-04-21 | Traditional | PDF ↗ |
| K941784 | VENTANA ANTI-CD8 PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-02-14 | Traditional | PDF ↗ |
| K941604 | VENTANA ANTI-CD4 PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-02-14 | Traditional | PDF ↗ |
| K941397 | ANTI-VIMENTIN PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-02-10 | Traditional | PDF ↗ |
| K941516 | VENTANNA ANTI-DESMIN PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-02-10 | Traditional | PDF ↗ |
| K941782 | VENTANA ANTI-CD5 PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1996-09-10 | Traditional | PDF ↗ |
| K951965 | DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION | Dako Corp. | 1996-07-05 | Traditional | PDF ↗ |
| K950148 | CHEMMATE(TM) CD43 | Biotek Solutions, Inc. | 1996-07-02 | Traditional | PDF ↗ |
| K941505 | VENTANNA ANTI-CD3 PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1996-05-30 | Traditional | PDF ↗ |
| K935161 | KERATIN PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1996-03-22 | Traditional | PDF ↗ |
| K941173 | ANTI-KERATIN-HMW PRIMARY ANTI-BODY | Ventana Medical Systems, Inc. | 1996-03-22 | Traditional | PDF ↗ |
| K936111 | CHEMMATE SPECIAL STAIN LCA-CD45 | Biotek Solutions, Inc. | 1996-02-27 | Traditional | PDF ↗ |
| K940331 | KERATIN PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1996-02-26 | Traditional | PDF ↗ |
| K950149 | CHEMMATE(TM) LAMBDA | Biotek Solutions, Inc. | 1995-12-06 | Traditional | PDF ↗ |
| K940424 | VENTANA BLUE DETECTION KIT | Ventana Medical Systems, Inc. | 1995-11-06 | Traditional | PDF ↗ |
| K950151 | CHEMMATE(TM) L26 (CD20) | Biotek Solutions, Inc. | 1995-10-04 | Traditional | PDF ↗ |
| K931192 | DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODY | Dako Corp. | 1995-04-20 | Traditional | PDF ↗ |
| K924804 | DAKO MOUSE ANTI-HUMAN T-CELL | Dako Corp. | 1994-11-21 | Traditional | PDF ↗ |
| K932136 | DAKO MOUSE ANTI-HUMAN MELANOMA (DAKO ANTI-HMB45) | Dako Corp. | 1994-06-13 | Traditional | PDF ↗ |
| K924726 | DAKO MOUSE ANTI-HUMAN B-CELL (DAKO-C020-L26 MONO ANTI | Dako Corp. | 1994-06-13 | Traditional | PDF ↗ |
| K932326 | PSA ANTIBODY KIT | Ventana Medical Systems, Inc. | 1993-08-06 | Traditional | PDF ↗ |
| K896918 | MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT | Dako Corp. | 1990-08-27 | Traditional | PDF ↗ |
| K902485 | BECKMAN LAMBDA LIGHT CHAIN REAGENT (ADD'L CLAIMS) | Beckman Instruments, Inc. | 1990-06-21 | Traditional | PDF ↗ |
| K875165 | QM300 LAMBDA LIGHT CHAINS ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-01-22 | Traditional | PDF ↗ |
| K855013 | QUANTIMETRIC PLUS SUPPORT PACK | Kallestad Laboratories, Inc. | 1986-02-26 | Traditional | PDF ↗ |
| K855007 | QUANTIMETRIC PLUS LAMBDA REAGENT KIT | Kallestad Laboratories, Inc. | 1986-02-26 | Traditional | PDF ↗ |
| K852999 | QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT | Kallestad Laboratories, Inc. | 1985-10-21 | Traditional | PDF ↗ |
| K842328 | AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN | Bartels Immunodiagnostic Supplies, Inc. | 1984-08-03 | Traditional | PDF ↗ |
| K841864 | QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT | Kallestad Laboratories, Inc. | 1984-07-11 | Traditional | PDF ↗ |
| K832270 | GOAT ANTI-HUMAN LAMBA | Gelco Diagnostics, Inc. | 1983-10-31 | Traditional | PDF ↗ |
| K832261 | GOAT ANTI-HUMAN LAMBA AFFINITY | Gelco Diagnostics, Inc. | 1983-10-28 | Traditional | PDF ↗ |
| K812662 | IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDA | Dako Corp. | 1981-09-29 | Traditional | PDF ↗ |
| K791283 | ANTI-HUMAN LAMBDA SERUM | Diagnostica, Inc. | 1979-11-27 | Traditional | PDF ↗ |
| K791115 | GOAR ANTI-HUMAN LAMBODA CHAIN | Protos Laboratories | 1979-08-03 | Traditional | PDF ↗ |
| K781220 | ANTI-HUMAN LAMBDA SERUM | Icl Scientific | 1978-07-27 | Traditional | PDF ↗ |
| K781025 | LAMBDA SERUM (FREE) ANTI-HUMAN | Icl Scientific | 1978-07-27 | Traditional | PDF ↗ |
| K771768 | GOAT LAMBDA-LIGHT CHAIN ANTI-HUMAN SERUM | G.D. Searle and Co. | 1977-10-07 | Traditional | PDF ↗ |
Product code DEH · Class II · Immunology. Data: openFDA.