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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K041871
Device Name INTERLAB MICROCAL SERUM CONTROLS
Applicant
Trouble Shooter Consuling, Inc.
Via Rina Monti N 26 C.A.P.
Rome,  IT 00155
Applicant Contact Gary Lehnus
Correspondent
Trouble Shooter Consuling, Inc.
Via Rina Monti N 26 C.A.P.
Rome,  IT 00155
Correspondent Contact Gary Lehnus
Regulation Number862.1660
Classification Product Code
JJX  
Date Received07/09/2004
Decision Date 08/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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