WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA

Lipoprotein, Low-density, Antigen, Antiserum, Control

WAKO CHEMICALS, USA, INC.

The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Autokit Lp(a) And Lp(a) Calibrator/cobas Fara.

Pre-market Notification Details

Device IDK001929
510k NumberK001929
Device Name:WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA
ClassificationLipoprotein, Low-density, Antigen, Antiserum, Control
Applicant WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond,  VA  23237
ContactTonya Mallory
CorrespondentTonya Mallory
WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond,  VA  23237
Product CodeDFC  
CFR Regulation Number866.5600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-06-26
Decision Date2000-07-24

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