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510(k) K894063

TRIGLYCERIDE (GPO) TRINDER REAGENT by Sigma Diagnostics, Inc. — Product Code JGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1989
Date Received
June 8, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetric Method, Triglycerides
Device Class
Class I
Regulation Number
862.1705
Review Panel
CH
Submission Type

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