510(k) K941063

DNA TRIGLYCERIDE PROCEDURE by Data Medical Associates, Inc. — Product Code JGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1994
Date Received
March 8, 1994
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