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 Plasma, Control, Normal
510(k) Number K984129
Device Name COAGULATION CONTROL LEVEL 1 (NORMAL)
Applicant
Pacific Hemostasis
11515 Vanstory Dr.
Huntersville,  NC  28078 -8144
Applicant Contact MARK ELLIS
Correspondent
Pacific Hemostasis
11515 Vanstory Dr.
Huntersville,  NC  28078 -8144
Correspondent Contact MARK ELLIS
Regulation Number864.5425
Classification Product Code
GIZ  
Date Received11/18/1998
Decision Date 12/01/1998
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
-
-