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FDA 510(k)

ROCHE ACETAMINOPHEN ASSAY

K-Number: K110726 · 2011-12-23

ApplicantRoche Diagnostics
Decision Date2011-12-23
Product CodeLDP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ROCHE ACETAMINOPHEN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2011-12-23 under 510(k) number K110726. The device is classified under product code LDP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE ACETAMINOPHEN ASSAY?

ROCHE ACETAMINOPHEN ASSAY is a medical device that received FDA 510(k) clearance on 2011-12-23. The listed applicant is Roche Diagnostics. The 510(k) number is K110726.

When did ROCHE ACETAMINOPHEN ASSAY receive FDA 510(k) clearance?

ROCHE ACETAMINOPHEN ASSAY received FDA 510(k) clearance on 2011-12-23, under 510(k) number K110726.

Who is the listed applicant for ROCHE ACETAMINOPHEN ASSAY?

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

What is the FDA product code for ROCHE ACETAMINOPHEN ASSAY?

The FDA product code for ROCHE ACETAMINOPHEN ASSAY is LDP.

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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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