DAKO MOUSE ANTI-HUMAN B-CELL (DAKO-C020-L26 MONO ANTI
FDA 510(k) clearance K924726 · decided 1994-06-13
Clearance details
- K-number
- K924726
- Device name
- DAKO MOUSE ANTI-HUMAN B-CELL (DAKO-C020-L26 MONO ANTI
- Applicant
- Dako Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-09-21
- Decision date
- 1994-06-13
- Days to decision
- 630 days
- Clearance type
- Traditional
- Product code
- DEH
- Device class
- 2
- Regulation number
- 866.5550
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Carpinteria, CA, US
- Third-party review
- No
- Expedited review
- No
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| LAMBDA LIGHT CHAINS (K083601) | SENTINEL CH. SpA | 2009-06-22 |
| FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER (K033811) | The Binding Site, Ltd. | 2004-01-30 |
| FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II (K031016) | The Binding Site, Ltd. | 2003-07-15 |
| FREELITE HUMAN LAMBDA FREE KIT (K023131) | The Binding Site, Ltd. | 2003-01-21 |
| FREELITE LAMBDA FREE KIT (K010440) | The Binding Site, Ltd. | 2001-04-26 |
| FREELITE KAPPA FREE KIT (K010441) | The Binding Site, Ltd. | 2001-04-26 |
| LAMBDA IMMAGE FREELITE KIT (K003671) | The Binding Site, Ltd. | 2001-02-01 |
| SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT (K002563) | The Binding Site, Ltd. | 2000-10-26 |
| DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING (K971905) | Dako Corp. | 1997-12-12 |
| MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751) (K965022) | Dako Corp. | 1997-11-06 |
Recalls involving this device
No recalls on record reference this clearance.