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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrators, Drug Specific
510(k) Number K973536
Device Name ACE PHENOBARBITAL REAGENT/AED CALIBRATORS
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 Number862.3200
Classification Product Code
DLJ  
Date Received09/18/1997
Decision Date 11/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
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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