System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations
PHJ is the FDA product code for System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations, a class II device type, regulated under 21 CFR 864.7280. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- PHJ
- Device name
- System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations
- FDA 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.
- Regulation
- 21 CFR 864.7280
- Device class
- Class II
- Review panel
- Hematology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code PHJ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2014 | 1 |
Applicants with the most clearances
Product code PHJ| Applicant | Clearances |
|---|---|
| Sequenom, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code PHJ.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.