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 Respiratory Syncytial Virus, Antigen, Antibody, Ifa
510(k) Number K942173
Device Name RSV ANTIGEN TEST
Applicant
Neogenex
12811 Eight Ave. W.
Suite A-101
Everett,  WA  98204
Applicant Contact D.F. ROBERTS
Correspondent
Neogenex
12811 Eight Ave. W.
Suite A-101
Everett,  WA  98204
Correspondent Contact D.F. ROBERTS
Regulation Number866.3480
Classification Product Code
LKT  
Date Received05/05/1994
Decision Date 06/30/1994
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
-
-