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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test
510(k) Number K161679
Device Name s LDL-EX SEIKEN
Applicant
Denka Seiken Co., Ltd.
1359-I, Kagamida, Kigoshi
Gosen,  JP 959-1695
Applicant Contact Takayoshi Ishii
Correspondent
Devices & Diagnostics Consulting Group, Inc.
16809 Briardale Rd.
Rockville,  MD  20855
Correspondent Contact Thomas M. Tsakeris
Regulation Number862.1475
Classification Product Code
PYP  
Date Received06/17/2016
Decision Date 08/18/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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