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510(k) K963424

OLYMPUS LIPASE REAGENT by Olympus America, Inc. — Product Code CDT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1997
Date Received
August 30, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Device Class
Class I
Regulation Number
862.1705
Review Panel
CH
Submission Type

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  • K020488 — CARESIDE TRGLYCERIDE (April 15, 2002)
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