DEN030005 is an FDA 510(k) submission for the FACTOR V LEIDEN KIT. This device is classified as a Test, Factor V Leiden Mutations, Genomic Dna Pcr (Class II - Special Controls, product code NPQ).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Not Cleared (DENG) decision on December 17, 2003.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.7280. In Vitro Diagnostic Test To Detect The Factor V Leiden Mutation In Genomic Dna, As An Aid To Diagnosis In The Evaluation Of Patients With Suspected Thrombophilia..
| 510(k) Number | DEN030005 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 08, 2003 |
| Decision Date | December 17, 2003 |
| Days to Decision | 9 days |
| Submission Type | Post-NSE |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | NPQ — Test, Factor V Leiden Mutations, Genomic Dna Pcr |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7280 |
| Definition | In Vitro Diagnostic Test To Detect The Factor V Leiden Mutation In Genomic Dna, As An Aid To Diagnosis In The Evaluation Of Patients With Suspected Thrombophilia. |