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FDA 510(k)

TINA-QUANT CRP (LATEX)

K-Number: K032336 · 2003-08-05

ApplicantRoche Diagnostics Corp.
Decision Date2003-08-05
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TINA-QUANT CRP (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 2003-08-05 under 510(k) number K032336. 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 TINA-QUANT CRP (LATEX)?

TINA-QUANT CRP (LATEX) is a medical device that received FDA 510(k) clearance on 2003-08-05. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K032336.

When did TINA-QUANT CRP (LATEX) receive FDA 510(k) clearance?

TINA-QUANT CRP (LATEX) received FDA 510(k) clearance on 2003-08-05, under 510(k) number K032336.

Who is the listed applicant for TINA-QUANT CRP (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 TINA-QUANT CRP (LATEX)?

The FDA product code for TINA-QUANT CRP (LATEX) is DCN.

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Related Devices (Code: 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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