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 Control, Plasma, Abnormal
510(k) Number K961370
Device Name LA POSITIVE CONTROL PLASMA
Applicant
Medical Diagnostic Technologies, Inc.
6025 Nicolle St.
Ventura,  CA  93003
Applicant Contact MICHAEL D BICK, PH.D.
Correspondent
Medical Diagnostic Technologies, Inc.
6025 Nicolle St.
Ventura,  CA  93003
Correspondent Contact MICHAEL D BICK, PH.D.
Regulation Number864.5425
Classification Product Code
GGC  
Date Received04/09/1996
Decision Date 05/24/1996
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
-
-