The following data is part of a premarket notification filed by Otisville Biotech, Inc. with the FDA for Phenylethyl Alcohol Agar Plate.
Device ID | K834422 |
510k Number | K834422 |
Device Name: | PHENYLETHYL ALCOHOL AGAR PLATE |
Classification | Culture Media, Selective And Non-differential |
Applicant | OTISVILLE BIOTECH, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JSJ |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-15 |
Decision Date | 1984-10-23 |