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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Sodium
510(k) Number K933862
Device Name ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE)
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 Number862.1665
Classification Product Code
JGS  
Subsequent Product Codes
CEM   CGZ  
Date Received08/09/1993
Decision Date 10/12/1993
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
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