The following data is part of a premarket notification filed by Otisville Biotech, Inc. with the FDA for Biotis Martin Lewis Agar.
Device ID | K843817 |
510k Number | K843817 |
Device Name: | BIOTIS MARTIN LEWIS AGAR |
Classification | Culture Media, For Isolation Of Pathogenic Neisseria |
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 | JTY |
CFR Regulation Number | 866.2410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-28 |
Decision Date | 1984-10-10 |