Quantex CRP High Sensitivity Standard Multipoint, Quantex CRP High Sensitivity Controls Ve Controls 1/2

FDA 510(k) K032663 · Instrumentation Laboratory CO

Substantially Equivalent

510(k) numberK032663

Submission

Device name
Quantex CRP High Sensitivity Standard Multipoint, Quantex CRP High Sensitivity Controls Ve Controls 1/2
Applicant
Instrumentation Laboratory CO
Bedford, MA, US
Received
August 28, 2003
Decision date
December 19, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DCK – C-Reactive Protein, Antigen, Antiserum, And Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5270
Specialty
Immunology

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Questions and answers

When was Quantex CRP High Sensitivity Standard Multipoint, Quantex CRP High Sensitivity Controls Ve Controls 1/2 cleared by the FDA?

Quantex CRP High Sensitivity Standard Multipoint, Quantex CRP High Sensitivity Controls Ve Controls 1/2 (K032663) received a 510(k) decision of Substantially Equivalent on December 19, 2003, 113 days after the submission was received.

What is the product code of K032663?

The FDA product code is DCK – C-Reactive Protein, Antigen, Antiserum, And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5270.