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FDA 510(k) Application Details - K170232
Device Classification Name
Radioimmunoassay, Thyroid-Stimulating Hormone
More FDA Info for this Device
510(K) Number
K170232
Device Name
Radioimmunoassay, Thyroid-Stimulating Hormone
Applicant
BODITECH MED INC.
43, GEODUDANJI 1-GIL, DONGNAE-MYEON
CHUNCHEON-SI KR
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Contact
HYUNG-JU OH
Other 510(k) Applications for this Contact
Regulation Number
862.1690
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Classification Product Code
JLW
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More FDA Info for this Product Code
Date Received
01/25/2017
Decision Date
10/13/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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