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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 K143373
Device Name IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material
Applicant
Siemens Healthcare Diagnostics, Inc.
5210 Pacific Concourse Dr.
Los Angeles,  CA  90045
Applicant Contact DONNA VELASQUEZ
Correspondent
Siemens Healthcare Diagnostics, Inc.
5210 Pacific Concourse Dr.
Los Angeles,  CA  90045
Correspondent Contact DONNA VELASQUEZ
Regulation Number862.1660
Classification Product Code
JJX  
Date Received11/25/2014
Decision Date 02/26/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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