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FDA 510(k)

VIDAS TESTOSTERONE (TES), MODEL 30 418

K-Number: K021326 · 2002-07-18

ApplicantbioMerieux, Inc.
Decision Date2002-07-18
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VIDAS TESTOSTERONE (TES), MODEL 30 418 is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2002-07-18 under 510(k) number K021326. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIDAS TESTOSTERONE (TES), MODEL 30 418?

VIDAS TESTOSTERONE (TES), MODEL 30 418 is a medical device that received FDA 510(k) clearance on 2002-07-18. The listed applicant is bioMerieux, Inc.. The 510(k) number is K021326.

When did VIDAS TESTOSTERONE (TES), MODEL 30 418 receive FDA 510(k) clearance?

VIDAS TESTOSTERONE (TES), MODEL 30 418 received FDA 510(k) clearance on 2002-07-18, under 510(k) number K021326.

Who is the listed applicant for VIDAS TESTOSTERONE (TES), MODEL 30 418?

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

What is the FDA product code for VIDAS TESTOSTERONE (TES), MODEL 30 418?

The FDA product code for VIDAS TESTOSTERONE (TES), MODEL 30 418 is CDZ.

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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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