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FDA 510(k)

TRIAGE TOX DRUG SCREEN CONTROLS

K-Number: K050037 · 2005-03-22

ApplicantBiosite Incorporated
Decision Date2005-03-22
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TRIAGE TOX DRUG SCREEN CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Biosite Incorporated. It received FDA 510(k) clearance on 2005-03-22 under 510(k) number K050037. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIAGE TOX DRUG SCREEN CONTROLS?

TRIAGE TOX DRUG SCREEN CONTROLS is a medical device that received FDA 510(k) clearance on 2005-03-22. The listed applicant is Biosite Incorporated. The 510(k) number is K050037.

When did TRIAGE TOX DRUG SCREEN CONTROLS receive FDA 510(k) clearance?

TRIAGE TOX DRUG SCREEN CONTROLS received FDA 510(k) clearance on 2005-03-22, under 510(k) number K050037.

Who is the listed applicant for TRIAGE TOX DRUG SCREEN CONTROLS?

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

What is the FDA product code for TRIAGE TOX DRUG SCREEN CONTROLS?

The FDA product code for TRIAGE TOX DRUG SCREEN CONTROLS is DIF.

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Related Devices (Code: DIF)

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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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