The following data is part of a premarket notification filed by Third Wave Technologies, Inc. with the FDA for Inplex Cf Molecular Test.
| Device ID | K063787 |
| 510k Number | K063787 |
| Device Name: | INPLEX CF MOLECULAR TEST |
| Classification | System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection |
| Applicant | THIRD WAVE TECHNOLOGIES, INC. 502 SOUTH ROSA RD. Madison, WI 53719 -1256 |
| Contact | Andrew A Lukowiak |
| Correspondent | Andrew A Lukowiak THIRD WAVE TECHNOLOGIES, INC. 502 SOUTH ROSA RD. Madison, WI 53719 -1256 |
| Product Code | NUA |
| CFR Regulation Number | 866.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-21 |
| Decision Date | 2008-03-13 |
| Summary: | summary |