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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 K964346
Device Name PARAMAX TRIGLYCERID REAGENT
Applicant
DADE INTL., INC.
9750 N.W. 25TH ST.
MIAMI,  FL  33172
Applicant Contact MARIAN HARDING COCHRAN, ESQ.
Correspondent
DADE INTL., INC.
9750 N.W. 25TH ST.
MIAMI,  FL  33172
Correspondent Contact MARIAN HARDING COCHRAN, ESQ.
Regulation Number862.1705
Classification Product Code
CDT  
Date Received10/31/1996
Decision Date 03/28/1997
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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