The following data is part of a premarket notification filed by Otisville Biotech, Inc. with the FDA for Nyc-gc Media.
Device ID | K832948 |
510k Number | K832948 |
Device Name: | NYC-GC MEDIA |
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 | 1983-08-30 |
Decision Date | 1983-09-29 |