The following data is part of a premarket notification filed by Osmetech Molecular Diagnostics with the FDA for Esensor Cf Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test, Esensor Instrument, Models Xt-8.
| Device ID | K090901 |
| 510k Number | K090901 |
| Device Name: | ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8 |
| Classification | System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection |
| Applicant | OSMETECH MOLECULAR DIAGNOSTICS 757 SOUTH RAYMOND AVE. Pasadena, CA 91105 |
| Contact | Robert S Dicheck |
| Correspondent | Robert S Dicheck OSMETECH MOLECULAR DIAGNOSTICS 757 SOUTH RAYMOND AVE. 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 | 2009-04-01 |
| Decision Date | 2009-07-06 |
| Summary: | summary |