The following data is part of a premarket notification filed by Celera Diagnostics with the FDA for Cystic Fibrosis Genotyping Assay, Model 6l20-01.
| Device ID | K062028 |
| 510k Number | K062028 |
| Device Name: | CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01 |
| Classification | System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection |
| Applicant | CELERA DIAGNOSTICS 1401 HARBOR BAY PKWY. Alameda, CA 94502 |
| Contact | Victoria Mackinnon |
| Correspondent | Victoria Mackinnon CELERA DIAGNOSTICS 1401 HARBOR BAY PKWY. Alameda, CA 94502 |
| Product Code | NUA |
| CFR Regulation Number | 866.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-18 |
| Decision Date | 2007-09-07 |
| Summary: | summary |