PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)

Respiratory Syncytial Virus, Antigen, Antibody, Ifa

DIAGNOSTIC PRODUCTS CORP.

The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Pathodx Respiratory Syncytial Virus (rsv).

Pre-market Notification Details

Device IDK943317
510k NumberK943317
Device Name:PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)
ClassificationRespiratory Syncytial Virus, Antigen, Antibody, Ifa
Applicant DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles,  CA  90045 -5597
ContactKenneth B Asarch
CorrespondentKenneth B Asarch
DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles,  CA  90045 -5597
Product CodeLKT  
CFR Regulation Number866.3480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-07-11
Decision Date1994-12-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05056080501796 K943317 000
05056080501789 K943317 000

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