The following data is part of a premarket notification filed by Curetis Gmbh with the FDA for Unyvero Lrt Bal Application.
| Device ID | K191967 |
| 510k Number | K191967 |
| Device Name: | Unyvero LRT BAL Application |
| Classification | Lower Respiratory Microbial Nucleic Acid Detection System |
| Applicant | Curetis GmbH Max-Eyth-Straße 42 Holzgerlingen, DE 71088 |
| Contact | Karsten Mueller |
| Correspondent | Gail Radcliffe Radcliffe Consulting, Inc. 231 Fairbanks Street West Boylston, MA 01583 |
| Product Code | QBH |
| CFR Regulation Number | 866.3985 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-23 |
| Decision Date | 2019-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260364750058 | K191967 | 000 |