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 Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
510(k) Number K913693
Device Name ENZYGNOST(R) ANTI-CMV/IGM
Applicant
Behring Diagnostics, Inc.
17 Chubb Way
Somerville,  NJ  08876
Applicant Contact JOHN E HUGHES
Correspondent
Behring Diagnostics, Inc.
17 Chubb Way
Somerville,  NJ  08876
Correspondent Contact JOHN E HUGHES
Regulation Number866.3175
Classification Product Code
LFZ  
Date Received08/19/1991
Decision Date 02/27/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-