The following data is part of a premarket notification filed by Clinical Convenience Products, Inc. with the FDA for Culturia Emb/columbia Cna W/5% Sheep.
| Device ID | K792284 |
| 510k Number | K792284 |
| Device Name: | CULTURIA EMB/COLUMBIA CNA W/5% SHEEP |
| Classification | Kit, Screening, Urine |
| Applicant | CLINICAL CONVENIENCE PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JXA |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-11-13 |
| Decision Date | 1979-12-19 |