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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lipase hydrolysis/glycerol kinase enzyme, triglycerides
510(k) Number K870827
Device Name INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT
Applicant
INTERSECT SYSTEMS, INC.
1606 E. KESSLER BLVD., #100
P.O. BOX 889
LONGVIEW,  WA  98632
Applicant Contact LESTER B GARRISON
Correspondent
INTERSECT SYSTEMS, INC.
1606 E. KESSLER BLVD., #100
P.O. BOX 889
LONGVIEW,  WA  98632
Correspondent Contact LESTER B GARRISON
Regulation Number862.1705
Classification Product Code
CDT  
Date Received03/03/1987
Decision Date 03/13/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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