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510(k) K063057

IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP by Diagnostic Products Corporation — Product Code NQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2006
Date Received
October 5, 2006
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
Submission Type

In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.

Other clearances by Diagnostic Products Corporation

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  • K060369 — STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK (May 4, 2006)