The following data is part of a premarket notification filed by Mdt Corp., Inc. with the FDA for Spor-test Culture Media.
Device ID | K801980 |
510k Number | K801980 |
Device Name: | SPOR-TEST CULTURE MEDIA |
Classification | Culture Media, Non-selective And Non-differential |
Applicant | MDT CORP., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSG |
CFR Regulation Number | 866.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-08-19 |
Decision Date | 1980-09-09 |