The following data is part of a premarket notification filed by Clinical Convenience Products, Inc. with the FDA for Culturia Macconkey-mug/modified Tsa Systems.
Device ID | K870502 |
510k Number | K870502 |
Device Name: | CULTURIA MACCONKEY-MUG/MODIFIED TSA SYSTEMS |
Classification | Culture Media, Selective And Differential |
Applicant | CLINICAL CONVENIENCE PRODUCTS, INC. P.O. BOX 7773 Madison, WI 53707 |
Contact | Todd Styka |
Correspondent | Todd Styka CLINICAL CONVENIENCE PRODUCTS, INC. P.O. BOX 7773 Madison, WI 53707 |
Product Code | JSI |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-04 |
Decision Date | 1987-02-26 |