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FDA 510(k), K001647, BN PROSPEC SYSTEM
FDA 510(k), K001647, BN PROSPEC SYSTEM
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510(K) Number: K001647
Device Name: BN PROSPEC SYSTEM
Manufacturer: DADE BEHRING, INC.
Device Classification Name: nephelometer
Regulation Number: 866.4540
Classification Product Code: JZW
Date Received: 05/30/2000
Decision Date: 09/26/2000
Regulation Medical Specialty: Immunology
Device Name: BN PROSPEC SYSTEM
Manufacturer: DADE BEHRING, INC.
Device Classification Name: nephelometer
Regulation Number: 866.4540
Classification Product Code: JZW
Date Received: 05/30/2000
Decision Date: 09/26/2000
Regulation Medical Specialty: Immunology
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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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