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510(k) K961281

TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60 by Diagnostic Chemicals , Ltd. — Product Code CDT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1996
Date Received
April 3, 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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