K033612 is an FDA 510(k) clearance for the FACTOR II (PROTHROMBIN) G20210A KIT. This device is classified as a Test, Factor Ii G20210a Mutations, Genomic Dna Pcr (Class II - Special Controls, product code NPR).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on December 18, 2003, 31 days after receiving the submission on November 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 Ii G20210a Mutation In Genomic Dna, As An Aid To Diagnosis In The Evaluation Of Patients With Suspected Thrombophilia..
| 510(k) Number | K033612 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2003 |
| Decision Date | December 18, 2003 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| Product Code | NPR — Test, Factor Ii G20210a 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 Ii G20210a Mutation In Genomic Dna, As An Aid To Diagnosis In The Evaluation Of Patients With Suspected Thrombophilia. |