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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Diphenylhydantoin
510(k) Number K944085
Device Name ACE(TM) CEDIA(R) PHENYTOIN ASSAY
Applicant
Schiapparelli Biosystems, Inc.
9033 Red Branch Rd.
Columbia,  MD  21045
Applicant Contact MARK A SPAIN
Correspondent
Schiapparelli Biosystems, Inc.
9033 Red Branch Rd.
Columbia,  MD  21045
Correspondent Contact MARK A SPAIN
Regulation Number862.3350
Classification Product Code
DIP  
Date Received08/22/1994
Decision Date 12/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
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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