The following data is part of a premarket notification filed by Otisville Biotech, Inc. with the FDA for Chocolate Agar Gc Base Plate.
Device ID | K840065 |
510k Number | K840065 |
Device Name: | CHOCOLATE AGAR GC BASE PLATE |
Classification | Culture Media, For Isolation Of Pathogenic Neisseria |
Applicant | OTISVILLE BIOTECH, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTY |
CFR Regulation Number | 866.2410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-09 |
Decision Date | 1984-02-13 |