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510(k) K960088

TRUE TRIGLYCERIDE by Diagnostic Chemicals , Ltd. — Product Code CDT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1996
Date Received
January 11, 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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