510(k) K033811
- Device
- FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER
- Applicant
- THE BINDING SITE, LTD.
- 510(k) number
- K033811
- Product code
- DEH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-01-30
- Date received
- 2003-12-09
- Regulation
- 866.5550
- Classification name
- Lambda, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAY H GELLER
- Address
- West Tower, Suite 4000 2425 W. Olympic Blvd. Santa Monica CA US 90404 90404
FDA Registration Numbers#
- 3019906
- 9614373
- 2032900
- 9610099
- 3003423869
- 3013059683
- 2083566
- 3012471076
- 9681753
- 3014271897
- 3009189893
- 2050010
- 1618982
- 8023024
- 2050012
- 9610806
- 3003961883
- 1649518
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DEH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172471 | VENTANA CD30 (Ber-H2) RxDx Assay | Ventana Medical Systems, Inc. | 2018-05-08 |
| K140396 | FREELITE HUMAN LAMBDA FREE KIT | The Binding Site Group , Ltd. | 2014-04-16 |
| K083601 | LAMBDA LIGHT CHAINS | SENTINEL CH. SpA | 2009-06-22 |
| K031016 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II | The Binding Site, Ltd. | 2003-07-15 |
| K023131 | FREELITE HUMAN LAMBDA FREE KIT | The Binding Site, Ltd. | 2003-01-21 |
| K010440 | FREELITE LAMBDA FREE KIT | The Binding Site, Ltd. | 2001-04-26 |
| K010441 | FREELITE KAPPA FREE KIT | The Binding Site, Ltd. | 2001-04-26 |
| K003671 | LAMBDA IMMAGE FREELITE KIT | The Binding Site, Ltd. | 2001-02-01 |
| K002563 | SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT | The Binding Site, Ltd. | 2000-10-26 |
| K971905 | DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING | Dako Corp. | 1997-12-12 |
| K965022 | MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751) | Dako Corp. | 1997-11-06 |
| K940583 | VENTANA CD45 PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-10-20 |
| K973393 | CHEMMATE LCA | Ventana Medical Systems, Inc. | 1997-09-25 |
| K941514 | VENTANA ANTI-S100 PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-04-25 |
| K941170 | VENTANA ANTI-MELANOMA PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-04-22 |
Legacy Summary#
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FDA Review#
Decision Summary