WAKO LIPASE CALIBRATOR

Calibrator, Primary

WAKO CHEMICALS, USA, INC.

The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Lipase Calibrator.

Pre-market Notification Details

Device IDK001002
510k NumberK001002
Device Name:WAKO LIPASE CALIBRATOR
ClassificationCalibrator, Primary
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 CodeJIS  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-29
Decision Date2000-05-24

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