The following data is part of a premarket notification filed by Mesa Biotech, Inc. with the FDA for Accula Flu A/flu B Test.
| Device ID | K171641 |
| 510k Number | K171641 |
| Device Name: | Accula Flu A/Flu B Test |
| Classification | Influenza A And Influenza B Multiplex Nucleic Acid Assay |
| Applicant | Mesa Biotech, Inc. 6190 Cornerstone Court, Suite 220 San Diego, CA 92121 |
| Contact | Barbara E. Stevens |
| Correspondent | Barbara E. Stevens Mesa Biotech, Inc. 6190 Cornerstone Court, Suite 220 San Diego, CA 92121 |
| Product Code | OZE |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Dual Track |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-02 |
| Decision Date | 2018-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B54010280 | K171641 | 000 |
| B54010270 | K171641 | 000 |
| B54010260 | K171641 | 000 |
| B54010240 | K171641 | 000 |
| B540FAB1100CWC0 | K171641 | 000 |
| B540FAB1100CW0 | K171641 | 000 |