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FDA 510(k)

Elecsys TSH assay, cobas e 801 Immunoassay analyzer

K-Number: K162606 · 2017-01-23

ApplicantRoche Diagnostics
Decision Date2017-01-23
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Elecsys TSH assay, cobas e 801 Immunoassay analyzer is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2017-01-23 under approval number K162606. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elecsys TSH assay, cobas e 801 Immunoassay analyzer?

Elecsys TSH assay, cobas e 801 Immunoassay analyzer is a medical device that received FDA 510(k) clearance on 2017-01-23. It is manufactured by Roche Diagnostics. The 510(k) number is K162606.

When was Elecsys TSH assay, cobas e 801 Immunoassay analyzer approved by the FDA?

Elecsys TSH assay, cobas e 801 Immunoassay analyzer received FDA 510(k) clearance on 2017-01-23, under approval number K162606.

What company makes Elecsys TSH assay, cobas e 801 Immunoassay analyzer?

Elecsys TSH assay, cobas e 801 Immunoassay analyzer is manufactured by Roche Diagnostics.

What is the FDA product code for Elecsys TSH assay, cobas e 801 Immunoassay analyzer?

The FDA product code for Elecsys TSH assay, cobas e 801 Immunoassay analyzer is JLW.

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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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