FDA 510(k), K093910, IMPROVACUTER GEL & CLOT ACTIVATOR TUBE

FDA 510(k), K093910, IMPROVACUTER GEL & CLOT ACTIVATOR TUBE

Regular price $49.00 USD
Regular price Sale price $49.00 USD
Sale Sold out
510(K) Number: K093910
Device Name: IMPROVACUTER GEL & CLOT ACTIVATOR TUBE
Manufacturer: Diana Hong
Device Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection
Regulation Number: JKA
Classification Product Code: KXA
Date Received: 12/22/2009
Decision Date: 07/12/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
  • 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. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.

View full details