K172913 is an FDA 510(k) clearance for the cobas Factor II and Factor V Test. This device is classified as a Test, Factor Ii G20210a Mutations, Genomic Dna Pcr (Class II - Special Controls, product code NPR).
Submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on January 12, 2018, 109 days after receiving the submission on September 25, 2017.
This device falls under the Hematology 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 | K172913 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2017 |
| Decision Date | January 12, 2018 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| 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. |