FDA Product Code GGP: Test, Qualitative And Quantitative Factor Deficiency
Leading manufacturers include Instrumentation Laboratory CO, Siemens Healthcare Diagnostics Products GmbH and Precision Biologic, Inc..
FDA 510(k) Cleared Test, Qualitative And Quantitative Factor Deficiency Devices (Product Code GGP)
About Product Code GGP - Regulatory Context
510(k) Submission Activity
190 total 510(k) submissions under product code GGP since 1977, with 190 receiving FDA clearance (average review time: 108 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.
FDA Review Time
FDA review times for GGP submissions have been consistent, averaging 108 days recently vs 108 days historically.
GGP devices are reviewed by the Hematology panel. Browse all Hematology devices →