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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 the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2017-01-23 under 510(k) 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. The listed applicant is Roche Diagnostics. The 510(k) number is K162606.

When did Elecsys TSH assay, cobas e 801 Immunoassay analyzer receive FDA 510(k) clearance?

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

Who is the listed applicant for Elecsys TSH assay, cobas e 801 Immunoassay analyzer?

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 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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Related Devices (Code: JLW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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