The following data is part of a premarket notification filed by Sequenom, Inc. with the FDA for Impact Dx Factor V Leiden And Factor Ii Genotyping Test.
| Device ID | K132978 |
| 510k Number | K132978 |
| Device Name: | IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST |
| Classification | System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations |
| Applicant | SEQUENOM, INC. 3595 JOHN HOPKINS COURT San Diego, CA 92121 |
| Contact | Robin Weiner |
| Correspondent | Robin Weiner SEQUENOM, INC. 3595 JOHN HOPKINS COURT San Diego, CA 92121 |
| Product Code | PHJ |
| CFR Regulation Number | 864.7280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-23 |
| Decision Date | 2014-06-13 |
| Summary: | summary |