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510(k) K161679

s LDL-EX SEIKEN by Denka Seiken Co., Ltd. — Product Code PYP

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 18, 2017
Date Received: June 17, 2016
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test
Device Class: Class I
Regulation Number: 862.1475
Review Panel: CH
Submission Type

For the quantitative determination of low-density lipoprotein (LDL) cholesterol sub-fractions.