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 Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
510(k) Number K822066
Device Name LEGIONELLA PNEUMOPHILA
Applicant
Biodan Medical Systems, Ltd.
P.O.B. 2012
Rehovot 76120
Israel,  IL
Correspondent
Biodan Medical Systems, Ltd.
P.O.B. 2012
Rehovot 76120
Israel,  IL
Regulation Number866.3300
Classification Product Code
LHL  
Date Received07/14/1982
Decision Date 09/21/1982
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
-
-