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 Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
510(k) Number K980376
Device Name THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
Applicant
Bayer Corp.
511 Benedict Ave.
Tarrytown,  NY  10591 - 509
Applicant Contact GABRIEL J MURACA, JR.
Correspondent
Bayer Corp.
511 Benedict Ave.
Tarrytown,  NY  10591 - 509
Correspondent Contact GABRIEL J MURACA, JR.
Regulation Number866.6010
Classification Product Code
LTJ  
Date Received01/30/1998
Decision Date 04/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-