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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
510(k) Number K971526
Device Name ACE HDL-C REAGENT
Applicant
Schiapparelli Biosystems, Inc.
368 Passaic Ave.
Fairfield,  NJ  07004
Applicant Contact STEVE DALESSIO
Correspondent
Schiapparelli Biosystems, Inc.
368 Passaic Ave.
Fairfield,  NJ  07004
Correspondent Contact STEVE DALESSIO
Regulation Number862.1475
Classification Product Code
LBS  
Subsequent Product Codes
JIX   JJY  
Date Received04/28/1997
Decision Date 05/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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