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 culture media, selective and differential
510(k) Number K860386
Device Name BIOTIS SF BROTH
Applicant
OTISVILLE BIOTECH, INC.
P.O. BOX 567
OTISVILLE,  NY  10963 -
Applicant Contact ERNEST M GREEN
Correspondent
OTISVILLE BIOTECH, INC.
P.O. BOX 567
OTISVILLE,  NY  10963 -
Correspondent Contact ERNEST M GREEN
Regulation Number866.2360
Classification Product Code
JSI  
Date Received02/03/1986
Decision Date 02/24/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-