The following data is part of a premarket notification filed by Intelligent Medical Devices, Inc with the FDA for Imdx Flu A/b And Rsv For Abbott M2000.
| Device ID | K131584 |
| 510k Number | K131584 |
| Device Name: | IMDX FLU A/B AND RSV FOR ABBOTT M2000 |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | INTELLIGENT MEDICAL DEVICES, INC 180 CABOT ST. Beverly, MA 01915 |
| Contact | Fran White |
| Correspondent | Fran White INTELLIGENT MEDICAL DEVICES, INC 180 CABOT ST. Beverly, MA 01915 |
| Product Code | OCC |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-31 |
| Decision Date | 2013-08-21 |
| Summary: | summary |