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U.S. Department of Health and Human Services

Product Classification
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Device test, phencyclidine (pcp), over the counter
Definition The phencyclidine test is an in vitro diagnostic test for the qualitative analysis of phencyclidine in human urine.
Physical State In vitro diagnostic device.
Technical Method Urine sample assay.
Target Area Urine.
Review Panel Toxicology
Product CodeNGM
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Unclassified Reason Pre-Amendment
Submission Type 510(k)
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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