K100943 is an FDA 510(k) clearance for the INVADER FACTOR II. This device is classified as a Test, Factor Ii G20210a Mutations, Genomic Dna Pcr (Class II - Special Controls, product code NPR).
Submitted by Hologic, Inc. (Malborough, US). The FDA issued a Cleared decision on June 2, 2011, 422 days after receiving the submission on April 6, 2010.
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 | K100943 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2010 |
| Decision Date | June 02, 2011 |
| Days to Decision | 422 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. |