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FDA 510(k)

C-REACTIVE PROTEIN (LATEX)

K-Number: K083444 · 2009-03-18

ApplicantRoche Diagnostics Corp.
Decision Date2009-03-18
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

C-REACTIVE PROTEIN (LATEX) is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2009-03-18 under 510(k) number K083444. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C-REACTIVE PROTEIN (LATEX)?

C-REACTIVE PROTEIN (LATEX) is a medical device that received FDA 510(k) clearance on 2009-03-18. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K083444.

When did C-REACTIVE PROTEIN (LATEX) receive FDA 510(k) clearance?

C-REACTIVE PROTEIN (LATEX) received FDA 510(k) clearance on 2009-03-18, under 510(k) number K083444.

Who is the listed applicant for C-REACTIVE PROTEIN (LATEX)?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C-REACTIVE PROTEIN (LATEX)?

The FDA product code for C-REACTIVE PROTEIN (LATEX) is DCN.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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