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510(k) K143373

IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material by Siemens Healthcare Diagnostics, Inc. — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2015
Date Received
November 25, 2014
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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