The following data is part of a premarket notification filed by Clinical Micro Sensors, Inc. with the FDA for Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800.
| Device ID | K060543 |
| 510k Number | K060543 |
| Device Name: | ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800 |
| Classification | System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection |
| Applicant | CLINICAL MICRO SENSORS, INC. 757 SOUTH RAYMOND AVE. Pasadena, CA 91105 |
| Contact | William Coty |
| Correspondent | William Coty CLINICAL MICRO SENSORS, INC. 757 SOUTH RAYMOND AVE. Pasadena, CA 91105 |
| Product Code | NUA |
| CFR Regulation Number | 866.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-01 |
| Decision Date | 2006-03-28 |
| Summary: | summary |