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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Multipurpose For In Vitro Coagulation Studies
510(k) Number K183390
Device Name QNext and DG-PT
Applicant
Diagnostic Grifols, S.A.
Passeig Fluvial, 24
Partes Del Valles,  ES 08150
Applicant Contact Joaquin Alberto Tamparillas
Correspondent
Diagnostic Grifols, S.A.
Passeig Fluvial, 24
Partes Del Valles,  ES 08150
Correspondent Contact Joaquin Alberto Tamparillas
Regulation Number864.5425
Classification Product Code
JPA  
Subsequent Product Codes
GJS   GKP  
Date Received12/06/2018
Decision Date 08/21/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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