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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K930104
Device Name ACE CLINICAL CHEMISTRY SYSTEM
Applicant
Schiapparelli Biosystems, Inc.
368 Passaic Ave.
Fairfield,  NJ  07004
Applicant Contact MARK A SPAIN
Correspondent
Schiapparelli Biosystems, Inc.
368 Passaic Ave.
Fairfield,  NJ  07004
Correspondent Contact MARK A SPAIN
Regulation Number862.1150
Classification Product Code
JIX  
Subsequent Product Codes
JJE   JJY  
Date Received01/11/1993
Decision Date 08/23/1993
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
Recalls CDRH Recalls
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