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FDA 510(k), K170005, FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)
FDA 510(k), K170005, FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)
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510(K) Number: K170005
Device Name: FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)
Manufacturer: LASSE POST MOLLER
Device Classification Name: Immunohistochemistry Assay, Antibody, Progesterone Receptor
Regulation Number: MXZ
Classification Product Code: KXA
Date Received: 01/03/2017
Decision Date: 12/21/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Pathology
Device Name: FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)
Manufacturer: LASSE POST MOLLER
Device Classification Name: Immunohistochemistry Assay, Antibody, Progesterone Receptor
Regulation Number: MXZ
Classification Product Code: KXA
Date Received: 01/03/2017
Decision Date: 12/21/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Pathology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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