WAKO DIRECT LDL-C

System, Test, Low Density, Lipoprotein

WAKO CHEMICALS, USA, INC.

The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Direct Ldl-c.

Pre-market Notification Details

Device IDK982271
510k NumberK982271
Device Name:WAKO DIRECT LDL-C
ClassificationSystem, Test, Low Density, Lipoprotein
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 CodeMRR  
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-06-29
Decision Date1998-09-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04987481164543 K982271 000
04987481164536 K982271 000

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