The following data is part of a premarket notification filed by Otisville Biotech, Inc. with the FDA for Biotis Bordet Gengou Agar.
Device ID | K862390 |
510k Number | K862390 |
Device Name: | BIOTIS BORDET GENGOU AGAR |
Classification | Culture Media, Enriched |
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 | KZI |
CFR Regulation Number | 866.2330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-06-24 |
Decision Date | 1986-07-03 |