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 Fibrin Split Products
510(k) Number K852512
Device Name THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT
Applicant
Pacific Hemostasis
2493 Portola Rd.
Ventura,  CA  93003
Applicant Contact MICHAEL D BICK
Correspondent
Pacific Hemostasis
2493 Portola Rd.
Ventura,  CA  93003
Correspondent Contact MICHAEL D BICK
Regulation Number864.7320
Classification Product Code
GHH  
Date Received06/12/1985
Decision Date 09/17/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-