VTEC-RPLA SEIKEN

Antisera, All Types, Escherichia Coli

DENKA SEIKEN'S

The following data is part of a premarket notification filed by Denka Seiken's with the FDA for Vtec-rpla Seiken.

Pre-market Notification Details

Device IDK981734
510k NumberK981734
Device Name:VTEC-RPLA SEIKEN
ClassificationAntisera, All Types, Escherichia Coli
Applicant DENKA SEIKEN'S 3-4-2 NIHONBASHI KAYABACHO, CHUO-KU Tokyo,  JP 103-0025
ContactKevin Mangan
CorrespondentKevin Mangan
DENKA SEIKEN'S 3-4-2 NIHONBASHI KAYABACHO, CHUO-KU Tokyo,  JP 103-0025
Product CodeGNA  
CFR Regulation Number866.3255 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-05-18
Decision Date1998-09-22
Summary:summary

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