MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI
FDA 510(k) clearance K120663 · decided 2013-02-12
Clearance details
- K-number
- K120663
- Device name
- MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI
- Applicant
- Dako North America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-03-05
- Decision date
- 2013-02-12
- Days to decision
- 344 days
- Clearance type
- Traditional
- Product code
- MYA
- Device class
- 2
- Regulation number
- 864.1860
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Carpinteria, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| C-Kit pharmDx (P040011/S003) | Dako North America, Inc. | 2017-05-16 |
| PD-L1 IHC NIVOLUMAB PHARMDX (P150027/S004) | Dako North America, Inc. | 2017-03-24 |
| PD-L1 IHC 28-8 PHARMDX (P150027/S003) | Dako North America, Inc. | 2017-02-24 |
| PD-L1 IHC 28-8 PHARMDX (Melanoma Indication) (P150027/S002) | Dako North America, Inc. | 2016-12-01 |
| PD-L1 IHC 28-8 PHARMDX (MELANOMA INDICATION) (P150027/S001) | Dako North America, Inc. | 2016-10-05 |
| PD-L1 IHC 28-8 pharmDx (P150027) | Dako North America, Inc. | 2016-01-23 |
| C-KIT PHARMDX (P040011/S002) | Dako North America, Inc. | 2012-11-02 |
| DAKO C-KIT PHARMDX (P040011/S001) | Dako North America, Inc. | 2007-04-23 |