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U.S. Department of Health and Human Services

Product Classification

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Device instrument, coagulation, automated
Regulation Description Coagulation instrument.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeGKP
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.5400
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Guidance Document
  • 510(k) Submissions for Coagulation Instruments - Guidance for Industry and FDA Staff
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible