The following data is part of a premarket notification filed by Microbiologics, Inc. with the FDA for Cepheid Xpert Gbs Lb Control Panel.
| Device ID | K182472 |
| 510k Number | K182472 |
| Device Name: | Cepheid Xpert GBS LB 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 | 2018-09-10 |
| Decision Date | 2018-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 70845357041219 | K182472 | 000 |