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U.S. Department of Health and Human Services

Product Classification

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Device ninhydrin and l-leucyl-l-alanine (fluorimetric), phenylalanine
Regulation Description Phenylalanine test system.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeJNB
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.1555
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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