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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 K890337
Device Name TRIGLYCERIDES - GPO REAGENT
Applicant
ALPKEM CORP.
BOX 1260
CLACKAMAS,  OR  97015
Applicant Contact RAYMOND L PAVITT
Correspondent
ALPKEM CORP.
BOX 1260
CLACKAMAS,  OR  97015
Correspondent Contact RAYMOND L PAVITT
Regulation Number862.1705
Classification Product Code
CDT  
Date Received01/23/1989
Decision Date 03/09/1989
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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