The following data is part of a premarket notification filed by Clinical Convenience Products, Inc. with the FDA for Culturia Macconkey-mug.
| Device ID | K934759 |
| 510k Number | K934759 |
| Device Name: | CULTURIA MACCONKEY-MUG |
| Classification | Kit, Screening, Urine |
| Applicant | CLINICAL CONVENIENCE PRODUCTS, INC. 3802 PACKERS AVE. P.O. BOX 7773 Madison, WI 53707 -7773 |
| Contact | Gerald Tjernagel |
| Correspondent | Gerald Tjernagel CLINICAL CONVENIENCE PRODUCTS, INC. 3802 PACKERS AVE. P.O. BOX 7773 Madison, WI 53707 -7773 |
| Product Code | JXA |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-04 |
| Decision Date | 1994-09-09 |