The following data is part of a premarket notification filed by Intelligent Medical Devices, Inc. with the FDA for Imdx Hsv-1/2 For Abbott M2000.
| Device ID | K140198 |
| 510k Number | K140198 |
| Device Name: | IMDX HSV-1/2 FOR ABBOTT M2000 |
| Classification | Herpes Simplex Virus Nucleic Acid Amplification Assay |
| 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 | OQO |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-27 |
| Decision Date | 2014-05-13 |
| Summary: | summary |