MODIFIED CEDIA DAU PCP ASSAY

Enzyme Immunoassay, Phencyclidine

BOEHRINGER MANNHEIM CORP.

The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Modified Cedia Dau Pcp Assay.

Pre-market Notification Details

Device IDK972963
510k NumberK972963
Device Name:MODIFIED CEDIA DAU PCP ASSAY
ClassificationEnzyme Immunoassay, Phencyclidine
Applicant BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. Concord,  CA  94524
ContactYvette Lloyd
CorrespondentYvette Lloyd
BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. Concord,  CA  94524
Product CodeLCM  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-11
Decision Date1997-09-22
Summary:summary

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