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FDA 510(k) Application Details - K980908
Device Classification Name
Acid, Lactic, Enzymatic Method
More FDA Info for this Device
510(K) Number
K980908
Device Name
Acid, Lactic, Enzymatic Method
Applicant
KDK CORP.
57 NISHIAKETA-CHO,
HIGASHI-KUJO, MINAMI-KU
KYOTO 601 JP
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Contact
KAZUO IKETAKI
Other 510(k) Applications for this Contact
Regulation Number
862.1450
More FDA Info for this Regulation Number
Classification Product Code
KHP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/10/1998
Decision Date
09/11/1998
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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