FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)
FDA 510(k) clearance K170005 · decided 2017-12-21
Clearance details
- K-number
- K170005
- Device name
- FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)
- Applicant
- Dako Denmark A/S
- Decision
- Substantially Equivalent
- Date received
- 2017-01-03
- Decision date
- 2017-12-21
- Days to decision
- 352 days
- Clearance type
- Traditional
- Product code
- MXZ
- Device class
- 2
- Regulation number
- 864.1860
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Golstrup, DK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HER2 CISH pharmDX Kit (P100024/S012) | Dako Denmark A/S | 2017-04-12 |
| HER2 CISH pharmDx Kit (P100024/S013) | Dako Denmark A/S | 2017-04-03 |
| HER2 CISH PHARMDX KIT (P100024/S011) | Dako Denmark A/S | 2017-03-24 |
| HER2 CISH PHARMDX KIT (P100024/S010) | Dako Denmark A/S | 2016-09-27 |
| HER2 CISH PHARMDX KIT (P100024/S009) | Dako Denmark A/S | 2016-04-12 |
| HER2 CISH PHARMDX KIT (P100024/S008) | Dako Denmark A/S | 2016-01-29 |
| HER2 CISH PHARMDX KIT (P100024/S007) | Dako Denmark A/S | 2015-09-10 |
| HER2 CISH PHARMDX KIT (P100024/S006) | Dako Denmark A/S | 2014-12-29 |