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FDA 510(k), K063224, GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL
FDA 510(k), K063224, GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL
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510(K) Number: K063224
Device Name: GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL
Manufacturer: GENTRIS CORPORATION
Device Classification Name: quality control material, genetics, dna
Regulation Number: 866.5910
Classification Product Code: NZB
Date Received: 10/24/2006
Decision Date: 12/22/2006
Regulation Medical Specialty: Microbiology
Device Name: GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL
Manufacturer: GENTRIS CORPORATION
Device Classification Name: quality control material, genetics, dna
Regulation Number: 866.5910
Classification Product Code: NZB
Date Received: 10/24/2006
Decision Date: 12/22/2006
Regulation Medical Specialty: Microbiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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