The following data is part of a premarket notification filed by Clinical Micro Sensors with the FDA for Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna Detection System, Model 4800.
| Device ID | K051435 |
| 510k Number | K051435 |
| Device Name: | ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800 |
| Classification | System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection |
| Applicant | CLINICAL MICRO SENSORS 757 SOUTH RAYMOND AVENUE Pasadena, CA 91105 |
| Contact | William A Coty |
| Correspondent | William A Coty CLINICAL MICRO SENSORS 757 SOUTH RAYMOND AVENUE Pasadena, CA 91105 |
| Product Code | NUA |
| CFR Regulation Number | 866.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-01 |
| Decision Date | 2006-01-19 |
| Summary: | summary |