The following data is part of a premarket notification filed by Mesa Biotech, Inc. with the FDA for Accula Rsv Test.
| Device ID | K181443 |
| 510k Number | K181443 |
| Device Name: | Accula RSV Test |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | Mesa Biotech, Inc. 6190 Cornerstone Court, Suite 220 San Diego, CA 92121 |
| Contact | Barbara Stevens |
| Correspondent | Barbara Stevens Mesa Biotech, Inc. 6190 Cornerstone Court, Suite 220 San Diego, CA 92121 |
| Product Code | OCC |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Dual Track |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-31 |
| Decision Date | 2018-11-23 |
| Summary: | summary |