The following data is part of a premarket notification filed by Otisville Biotech, Inc. with the FDA for Biotis Kf Streptococcus Agar.
Device ID | K860388 |
510k Number | K860388 |
Device Name: | BIOTIS KF STREPTOCOCCUS AGAR |
Classification | Culture Media, Selective And Differential |
Applicant | OTISVILLE BIOTECH, INC. P.O. BOX 567 Otisville , NY 10963 - |
Contact | Ernest M Green |
Correspondent | Ernest M Green OTISVILLE BIOTECH, INC. P.O. BOX 567 Otisville , NY 10963 - |
Product Code | JSI |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-03 |
Decision Date | 1986-02-24 |