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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photometric Method, Iron (Non-Heme)
510(k) Number K944911
Device Name ACE IRON REAGENT
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 Number862.1410
Classification Product Code
JIY  
Date Received10/05/1994
Decision Date 02/10/1995
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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