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FDA 510(k)

TSH-CTK-3 IRMA

K-Number: K041014 · 2004-07-14

ApplicantDiaSorin, Inc.
Decision Date2004-07-14
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TSH-CTK-3 IRMA is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2004-07-14 under 510(k) number K041014. 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 TSH-CTK-3 IRMA?

TSH-CTK-3 IRMA is a medical device that received FDA 510(k) clearance on 2004-07-14. The listed applicant is DiaSorin, Inc.. The 510(k) number is K041014.

When did TSH-CTK-3 IRMA receive FDA 510(k) clearance?

TSH-CTK-3 IRMA received FDA 510(k) clearance on 2004-07-14, under 510(k) number K041014.

Who is the listed applicant for TSH-CTK-3 IRMA?

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

What is the FDA product code for TSH-CTK-3 IRMA?

The FDA product code for TSH-CTK-3 IRMA 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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