G-GT STANDARD CALIBRATOR

Calibrator, Secondary

WAKO CHEMICALS, USA, INC.

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

Pre-market Notification Details

Device IDK871759
510k NumberK871759
Device Name:G-GT STANDARD CALIBRATOR
ClassificationCalibrator, Secondary
Applicant WAKO CHEMICALS, USA, INC. 12300 FORD RD. SUITE 130 Dallas,  TX  75234
ContactToshihiko Oda
CorrespondentToshihiko Oda
WAKO CHEMICALS, USA, INC. 12300 FORD RD. SUITE 130 Dallas,  TX  75234
Product CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-05-05
Decision Date1987-09-29

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