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 Test, Sickle Cell
510(k) Number K872217
Device Name THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING 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 Number864.7825
Classification Product Code
GHM  
Date Received06/09/1987
Decision Date 07/31/1987
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
-
-