FDA 510(k), K994349, COAGUCHEK S SYSTEM, MODEL 2138280

FDA 510(k), K994349, COAGUCHEK S SYSTEM, MODEL 2138280

Regular price $49.00 USD
Regular price Sale price $49.00 USD
Sale Sold out
510(K) Number: K994349
Device Name: COAGUCHEK S SYSTEM, MODEL 2138280
Manufacturer: ROCHE DIAGNOSTICS CORP.
Device Classification Name: system, multipurpose for in vitro coagulation studies
Regulation Number: 864.5425
Classification Product Code: JPA
Date Received: 12/23/1999
Decision Date: 09/06/2000
Regulation Medical Specialty: Hematology
  • 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