CEDIA N-ACETYLPROCAINAMIDE ASSAY

Enzyme Immunoassay, Procainamide

BOEHRINGER MANNHEIM CORP.

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

Pre-market Notification Details

Device IDK963306
510k NumberK963306
Device Name:CEDIA N-ACETYLPROCAINAMIDE ASSAY
ClassificationEnzyme Immunoassay, Procainamide
Applicant BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. P.O. BOX 4117 Concord,  CA  94524 -4117
ContactBesty Soares-maddox
CorrespondentBesty Soares-maddox
BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. P.O. BOX 4117 Concord,  CA  94524 -4117
Product CodeLAR  
CFR Regulation Number862.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-08-22
Decision Date1996-10-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884883005617 K963306 000

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