FDA 510(k), K050002, VITEK 2 COMPACT

FDA 510(k), K050002, VITEK 2 COMPACT

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510(K) Number: K050002
Device Name: VITEK 2 COMPACT
Manufacturer: BIOMERIEUX, INC.
Device Classification Name: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Regulation Number: 866.1645
Classification Product Code: LON
Date Received: 01/03/2005
Decision Date: 02/17/2005
Regulation Medical Specialty: Microbiology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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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