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FDA 510(k), K121455, BACT/ALERT FN PLUS CULTURE BOTTLE
FDA 510(k), K121455, BACT/ALERT FN PLUS CULTURE BOTTLE
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510(K) Number: K121455
Device Name: BACT/ALERT FN PLUS CULTURE BOTTLE
Manufacturer: BIOMERIEUX, INC.
Device Classification Name: system, blood culturing
Regulation Number: 866.2560
Classification Product Code: MDB
Date Received: 05/16/2012
Decision Date: 01/25/2013
Regulation Medical Specialty: Microbiology
Device Name: BACT/ALERT FN PLUS CULTURE BOTTLE
Manufacturer: BIOMERIEUX, INC.
Device Classification Name: system, blood culturing
Regulation Number: 866.2560
Classification Product Code: MDB
Date Received: 05/16/2012
Decision Date: 01/25/2013
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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