The following data is part of a premarket notification filed by Iquum, Inc. with the FDA for Cobas Influenza A/b & Rsv Nucleic Acid Test For Use On The Cobas Liat System.
| Device ID | K153544 |
| 510k Number | K153544 |
| Device Name: | Cobas Influenza A/B & RSV Nucleic Acid Test For Use On The Cobas Liat System |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | IQuum, Inc. 700 Nickerson Road Marlborough, MA 01752 |
| Contact | Lingjun Chen |
| Correspondent | David W Gates IQuum, Inc. 4300 Hacienda Drive Pleasanton, CA 94588 |
| Product Code | OCC |
| Subsequent Product Code | OOI |
| Subsequent Product Code | OZE |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Dual Track |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-11 |
| Decision Date | 2016-07-25 |
| Summary: | summary |