MICROLINE SCREEN FOR PHENCYCLIDINE

Enzyme Immunoassay, Phencyclidine

DRUG SCREENING SYSTEMS, INC.

The following data is part of a premarket notification filed by Drug Screening Systems, Inc. with the FDA for Microline Screen For Phencyclidine.

Pre-market Notification Details

Device IDK921651
510k NumberK921651
Device Name:MICROLINE SCREEN FOR PHENCYCLIDINE
ClassificationEnzyme Immunoassay, Phencyclidine
Applicant DRUG SCREENING SYSTEMS, INC. 603 VPR COMMERCE CENTER P.O. BOX 579 Blackwood,  NJ  08012
ContactKenneth S Carpenter
CorrespondentKenneth S Carpenter
DRUG SCREENING SYSTEMS, INC. 603 VPR COMMERCE CENTER P.O. BOX 579 Blackwood,  NJ  08012
Product CodeLCM  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-04-06
Decision Date1992-07-08

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