GGP

Test, Qualitative And Quantitative Factor Deficiency

Product code
GGP
Device name
Test, Qualitative And Quantitative Factor Deficiency
Device class
Class 2
21 CFR
21 CFR 864.7290
Medical specialty
Hematology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
190 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-08-25.

NumberDecision dateApplicantDevice nameSummary
K2514402025-08-25Precision Biologic, Inc.CRYOcheck Chromogenic Factor VIIIPDF
K2308522023-12-13Instrumentation Laboratory CompanyHemosIL Chromogenic Factor IXPDF

2 summaries are archived here for direct download.

Official FDA classification page: GGP
Classification and pathway per current FDA publications. Data from openFDA (CC0).