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 Antiserum, Murine Typhus Fever
510(k) Number K860557
Device Name LATEX R. TYPHI
Applicant
Health Research, Inc.
1315 Empire State Plz.
Mayor Erastus Corning 2 Tower
Albany,  NY  12237
Applicant Contact MICHAEL G BARTH
Correspondent
Health Research, Inc.
1315 Empire State Plz.
Mayor Erastus Corning 2 Tower
Albany,  NY  12237
Correspondent Contact MICHAEL G BARTH
Regulation Number866.3500
Classification Product Code
GPM  
Date Received02/14/1986
Decision Date 04/21/1986
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
-
-