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, Multipurpose For In Vitro Coagulation Studies
510(k) Number K980839
Device Name AVOCET PT
Applicant
Avocet Medical, Inc.
1696 Dell Ave.
Campbell,  CA  95008
Applicant Contact Judith Blunt
Correspondent
Avocet Medical, Inc.
1696 Dell Ave.
Campbell,  CA  95008
Correspondent Contact Judith Blunt
Regulation Number864.5425
Classification Product Code
JPA  
Date Received03/04/1998
Decision Date 09/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-