The following data is part of a premarket notification filed by Otisville Biotech, Inc. with the FDA for Biotis Middlebrook 7h11 Broth & Agar Slant.
Device ID | K860391 |
510k Number | K860391 |
Device Name: | BIOTIS MIDDLEBROOK 7H11 BROTH & AGAR SLANT |
Classification | Culture Media, Selective And Non-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 | JSJ |
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 |