The following data is part of a premarket notification filed by Microbiologics, Inc. with the FDA for Cepheid Xpert C. Difficile/epi Control Panel.
| Device ID | K190463 |
| 510k Number | K190463 |
| Device Name: | Cepheid Xpert C. Difficile/Epi Control Panel |
| Classification | Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays |
| Applicant | Microbiologics, Inc. 200 Cooper Avenue North St. Cloud, MN 56303 |
| Contact | Tina Sobania |
| Correspondent | Tina Sobania Microbiologics, Inc. 200 Cooper Avenue North St. Cloud, MN 56303 |
| Product Code | PMN |
| CFR Regulation Number | 866.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-26 |
| Decision Date | 2019-04-19 |