PHJ · Class II · 21 CFR 864.7280

FDA Product Code PHJ: System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations

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.

1
Total
1
Cleared
263d
Avg days
2014
Since

FDA 510(k) Cleared System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations Devices (Product Code PHJ)

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About Product Code PHJ - Regulatory Context