PHJ — System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations Class II
FDA product code PHJ covers "System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations", a Class II medical device regulated under 21 CFR 864.7280. Submissions are reviewed by the Hematology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PHJ
- Device Class
- Class II
- Regulation Number
- 864.7280
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
Definition
A multiplex genotying test system intended for the qualitative detection and identification of specific thrombophilia related gene mutations from genomic DNA by genomic amplification and mass spectrometry. It is intended as an aid in diagnosis of patients with suspected thrombophilia.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K132978 | sequenom | IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST | June 13, 2014 |