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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Low Density, Lipoprotein
510(k) Number K991733
Device Name ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS
Applicant
Schiapparelli Biosystems, Inc.
368 Passaic Ave.
Fairfield,  NJ  07004
Applicant Contact STEVEN DALESSIO
Correspondent
Schiapparelli Biosystems, Inc.
368 Passaic Ave.
Fairfield,  NJ  07004
Correspondent Contact STEVEN DALESSIO
Regulation Number862.1475
Classification Product Code
MRR  
Subsequent Product Codes
JIS   JJX  
Date Received05/21/1999
Decision Date 07/13/1999
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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