ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST

Enzyme Immunoassay, Phencyclidine

TCPI, INC.

The following data is part of a premarket notification filed by Tcpi, Inc. with the FDA for One Step Urine Drug Of Abuse: Phencyclidine (pcp) Test.

Pre-market Notification Details

Device IDK981363
510k NumberK981363
Device Name:ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST
ClassificationEnzyme Immunoassay, Phencyclidine
Applicant TCPI, INC. P.O. BOX 8726 Ft. Lauderdale,  FL  33310
ContactJeffrey Bolts
CorrespondentJeffrey Bolts
TCPI, INC. P.O. BOX 8726 Ft. Lauderdale,  FL  33310
Product CodeLCM  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-15
Decision Date1998-12-22
Summary:summary

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