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 Radioimmunoassay, Testosterones And Dihydrotestosterone
510(k) Number K955102
Device Name BIODATA TESTOSTERONE MAIA KIT
Applicant
Biochem Immunosystems (U.S.), Inc.
100 Cascade Dr.
Allentown,  PA  18103
Applicant Contact LAURENCE A POTTER
Correspondent
Biochem Immunosystems (U.S.), Inc.
100 Cascade Dr.
Allentown,  PA  18103
Correspondent Contact LAURENCE A POTTER
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received11/08/1995
Decision Date 06/24/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-