The following data is part of a premarket notification filed by Iquum Inc with the FDA for Liat (tm) Influenza A / B Assay, Liat (tm) Analyzer.
| Device ID | K111387 |
| 510k Number | K111387 |
| Device Name: | LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | IQUUM INC 700 NICKERSON ROAD Marlborough, MA 01762 -4663 |
| Contact | Lingjun Chen |
| Correspondent | Lingjun Chen IQUUM INC 700 NICKERSON ROAD Marlborough, MA 01762 -4663 |
| Product Code | OCC |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-17 |
| Decision Date | 2011-08-04 |
| Summary: | summary |