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 Discs, Strips And Reagents, Microorganism Differentiation
510(k) Number K970009
Device Name LYFO(TM) DIFFERENTIAL DISK-BACITRACIN
Applicant
Microbiologics, Inc.
217 Osseo Ave. N.
St. Cloud,  MN  56303
Applicant Contact GERI HOTZ
Correspondent
Microbiologics, Inc.
217 Osseo Ave. N.
St. Cloud,  MN  56303
Correspondent Contact GERI HOTZ
Regulation Number866.2660
Classification Product Code
JTO  
Date Received01/02/1997
Decision Date 02/06/1997
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
-
-