510(k) K800551

TRIGLYCERIDES TEST (500NM) by Reagents Applications, Inc. — Product Code JGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1980
Date Received
March 10, 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