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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetric Method, Triglycerides
510(k) Number K954187
Device Name TRIGLYCERIDES REAGENT
Applicant
Schiapparelli Biosystems, Inc.
368 Passaic Ave.
Fairfield,  NJ  07004
Applicant Contact ROBERT J PAQUET
Correspondent
Schiapparelli Biosystems, Inc.
368 Passaic Ave.
Fairfield,  NJ  07004
Correspondent Contact ROBERT J PAQUET
Regulation Number862.1705
Classification Product Code
JGY  
Date Received09/06/1995
Decision Date 10/23/1995
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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