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 K875361
Device Name SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT
Applicant
Disease Detection International, Inc.
17935 Sky Park Circle, Suite
D
Irvine,  CA  92714
Applicant Contact EL-BADRY
Correspondent
Disease Detection International, Inc.
17935 Sky Park Circle, Suite
D
Irvine,  CA  92714
Correspondent Contact EL-BADRY
Regulation Number866.3175
Classification Product Code
LFZ  
Date Received12/31/1987
Decision Date 05/13/1988
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
-
-