NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1)
FDA 510(k) clearance K061360 · decided 2006-06-27
Clearance details
- K-number
- K061360
- Device name
- NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1)
- Applicant
- Lab Vision Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-05-16
- Decision date
- 2006-06-27
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- MYA
- Device class
- 2
- Regulation number
- 864.1860
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
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| MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI (K120663) | Dako North America, Inc. | 2013-02-12 |
| CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY (K110215) | Ventana Medical Systems, Inc. | 2012-12-17 |
| MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634 (K081286) | Dako North America, Inc. | 2009-05-08 |
| VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) (K060227) | Vision Biosystems, Inc. | 2006-05-25 |
| MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) (K012138) | Chroma Vision Medical Systems, Inc. | 2002-09-30 |
| BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) (K013148) | Biogenex Laboratories | 2002-02-28 |
| DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR (K993957) | Dako Corp. | 2000-03-03 |
| VENTANA ER PRIMARY ANTIBODY (CLONE 6F11) (K984567) | Ventana, Inc. | 1999-08-12 |
Recalls involving this device
No recalls on record reference this clearance.