Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name System, Automated Platelet Aggregation
510(k) Number K051231
Device Name VERIFYNOW-P2Y12 ASSAY
Applicant
ACCUMETRICS, INC.
3985 SORRENTO VALLEY BLVD.
SAN DIEGO,  CA  92121
Applicant Contact BARBARA STEVENS
Correspondent
ACCUMETRICS, INC.
3985 SORRENTO VALLEY BLVD.
SAN DIEGO,  CA  92121
Correspondent Contact BARBARA STEVENS
Regulation Number864.5700
Classification Product Code
JOZ  
Date Received05/13/2005
Decision Date 08/05/2005
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
Recalls CDRH Recalls
-
-