510(k) K801012

TRIGLYCERIDE REAGENT (COLOR) by Gilford Diagnostics — Product Code JGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1980
Date Received
April 28, 1980
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