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FDA 510(k)

ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2

K-Number: K040435 · 2004-03-10

ApplicantRoche Diagnostics Corp.
Decision Date2004-03-10
Product CodeCZP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 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 2004-03-10 under 510(k) number K040435. The device is classified under product code CZP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2?

ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 is a medical device that received FDA 510(k) clearance on 2004-03-10. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K040435.

When did ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 receive FDA 510(k) clearance?

ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 received FDA 510(k) clearance on 2004-03-10, under 510(k) number K040435.

Who is the listed applicant for ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2?

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 ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2?

The FDA product code for ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 is CZP.

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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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