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 Reagent, Borrelia Serological Reagent
510(k) Number K901054
Device Name BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE
Applicant
Bion Ent., Ltd.
674 Busse Hwy.
Park Ridge,  IL  60068
Applicant Contact EDWARD NOWAKOWSKI
Correspondent
Bion Ent., Ltd.
674 Busse Hwy.
Park Ridge,  IL  60068
Correspondent Contact EDWARD NOWAKOWSKI
Regulation Number866.3830
Classification Product Code
LSR  
Date Received03/06/1990
Decision Date 04/05/1990
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
-
-