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, Rotavirus
510(k) Number K942286
Device Name DIARLEX ROTA-ADENO
Applicant
Orion Diagnostica, Inc.
P.O. Box 83
02101 Espoo,  FI
Applicant Contact TIMO RAINES
Correspondent
Orion Diagnostica, Inc.
P.O. Box 83
02101 Espoo,  FI
Correspondent Contact TIMO RAINES
Regulation Number866.3405
Classification Product Code
LIQ  
Date Received04/22/1994
Decision Date 12/14/1994
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
-
-