The following data is part of a premarket notification filed by Clinical Micro Sensors, Inc. with the FDA for Esensor Respiratory Viral Panel.
| Device ID | K113731 |
| 510k Number | K113731 |
| Device Name: | ESENSOR RESPIRATORY VIRAL PANEL |
| Classification | Clinical Sample Concentrator |
| Applicant | CLINICAL MICRO SENSORS, INC. 5964 LA PLACE COURT Carlsbad, CA 92008 |
| Contact | Joel Centeno |
| Correspondent | Joel Centeno CLINICAL MICRO SENSORS, INC. 5964 LA PLACE COURT Carlsbad, CA 92008 |
| Product Code | JJH |
| Subsequent Product Code | NSU |
| Subsequent Product Code | OCC |
| Subsequent Product Code | OEM |
| Subsequent Product Code | OEP |
| Subsequent Product Code | OOU |
| Subsequent Product Code | OQW |
| Subsequent Product Code | OUL |
| CFR Regulation Number | 862.2310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-19 |
| Decision Date | 2012-09-10 |
| Summary: | summary |