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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrators, Drug Mixture
510(k) Number K141928
Device Name COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR
Applicant
Roche Diagnostics Operations (Rdo)
9115 Hague Rd.
Indianapolos,  IN  46250
Applicant Contact NOEL K MENCIAS
Correspondent
Roche Diagnostics Operations (Rdo)
9115 Hague Rd.
Indianapolos,  IN  46250
Correspondent Contact NOEL K MENCIAS
Regulation Number862.3200
Classification Product Code
DKB  
Subsequent Product Code
LDP  
Date Received07/16/2014
Decision Date 11/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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