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U.S. Department of Health and Human Services

Product Classification
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Device system, test, osteocalcin
Regulation Description Alkaline phosphatase or isoenzymes test system.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeNEO
Submission Type 510(k)
Regulation Number 862.1050
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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