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U.S. Department of Health and Human Services

Product Classification

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Device solution, stabilized enzyme
Regulation Description Stabilized enzyme solution.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeKSK
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type 510(k)
Regulation Number 864.9400
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible