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U.S. Department of Health and Human Services

Product Classification

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Device system, multipurpose for in vitro coagulation studies
Regulation Description Multipurpose system for in vitro coagulation studies.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeJPA
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.5425
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • 510(k) Submissions for Coagulation Instruments - Guidance for Industry and FDA Staff
Third Party Review
Accredited Persons

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