LP(A)-LATEX SEIKEN ASSAY KIT

Lipoprotein, Low-density, Antigen, Antiserum, Control

DENKA SEIKEN'S

The following data is part of a premarket notification filed by Denka Seiken's with the FDA for Lp(a)-latex Seiken Assay Kit.

Pre-market Notification Details

Device IDK013359
510k NumberK013359
Device Name:LP(A)-LATEX SEIKEN ASSAY KIT
ClassificationLipoprotein, Low-density, Antigen, Antiserum, Control
Applicant DENKA SEIKEN'S 3-4-2 NIHONBASHI KAYABACHO, CHUO-KU Tokyo,  JP 103-0025
ContactYousuke Meguro
CorrespondentYousuke Meguro
DENKA SEIKEN'S 3-4-2 NIHONBASHI KAYABACHO, CHUO-KU Tokyo,  JP 103-0025
Product CodeDFC  
CFR Regulation Number866.5600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-10-10
Decision Date2002-03-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00811727011831 K013359 000
00811727011824 K013359 000
00817439021090 K013359 000
00817439021069 K013359 000

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