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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 K862033
Device Name TRIGLYCERIDES
Applicant
Pointe Scientific, Inc.,
P.O. Box 8569
Detroit,  MI  48224
Applicant Contact JANUSZ M SZYSZKO
Correspondent
Pointe Scientific, Inc.,
P.O. Box 8569
Detroit,  MI  48224
Correspondent Contact JANUSZ M SZYSZKO
Regulation Number862.1705
Classification Product Code
CDT  
Date Received05/28/1986
Decision Date 07/22/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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