FDA 510(k), K974620, AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
FDA 510(k), K974620, AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
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510(K) Number: K974620
Device Name: AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
Manufacturer: TRACE AMERICA, INC.
Device Classification Name: enzymatic method, ammonia
Regulation Number: 862.1065
Classification Product Code: JIF
Date Received: 12/11/1997
Decision Date: 01/02/1998
Regulation Medical Specialty: Clinical Chemistry
Device Name: AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
Manufacturer: TRACE AMERICA, INC.
Device Classification Name: enzymatic method, ammonia
Regulation Number: 862.1065
Classification Product Code: JIF
Date Received: 12/11/1997
Decision Date: 01/02/1998
Regulation Medical Specialty: Clinical Chemistry
- 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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