The following data is part of a premarket notification filed by Clinical Convenience Products, Inc. with the FDA for Culturia Macconkey-mug/cled Systems.
| Device ID | K864764 |
| 510k Number | K864764 |
| Device Name: | CULTURIA MACCONKEY-MUG/CLED 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 | 1986-12-05 |
| Decision Date | 1986-12-29 |