CEDIA PHENYTOIN II ASSAY

Enzyme Immunoassay, Diphenylhydantoin

BOEHRINGER MANNHEIM CORP.

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

Pre-market Notification Details

Device IDK963840
510k NumberK963840
Device Name:CEDIA PHENYTOIN II ASSAY
ClassificationEnzyme Immunoassay, Diphenylhydantoin
Applicant BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. Concord,  CA  94524
ContactYvette Lloyd
CorrespondentYvette Lloyd
BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. Concord,  CA  94524
Product CodeDIP  
CFR Regulation Number862.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-09-24
Decision Date1996-11-20
Summary:summary

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