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FDA 510(k)

ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2

K-Number: K040431 · 2004-03-10

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

Device Summary

ROCHE DIAGNOSTICS TINA-QUANT IGM 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 K040431. The device is classified under product code DAO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

ROCHE DIAGNOSTICS TINA-QUANT IGM 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 K040431.

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

ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 received FDA 510(k) clearance on 2004-03-10, under 510(k) number K040431.

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

The FDA product code for ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 is DAO.

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Related Devices (Code: DAO)

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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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