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U.S. Department of Health and Human Services

Product Classification

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Device test, occult blood, over the counter
Regulation Description Occult blood test.
Regulation Medical Specialty Hematology
Review Panel Toxicology
Product CodeNGK
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.6550
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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