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FDA 510(k), K131804, REMEL XPECT FLU A&B
FDA 510(k), K131804, REMEL XPECT FLU A&B
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510(K) Number: K131804
Device Name: REMEL XPECT FLU A&B
Manufacturer: REMEL, INC.
Device Classification Name: antigens, cf (including cf control), influenza virus a, b, c
Regulation Number: 866.3330
Classification Product Code: GNX
Date Received: 06/19/2013
Decision Date: 07/12/2013
Regulation Medical Specialty: Microbiology
Device Name: REMEL XPECT FLU A&B
Manufacturer: REMEL, INC.
Device Classification Name: antigens, cf (including cf control), influenza virus a, b, c
Regulation Number: 866.3330
Classification Product Code: GNX
Date Received: 06/19/2013
Decision Date: 07/12/2013
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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