FDA 510(k)

TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002

K-Number: K013002 · 2001-10-03

Decision Date2001-10-03

Product CodeDIF

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002 is the device name listed in this FDA 510(k) record. The listed applicant is Biosite Incorporated. It received FDA 510(k) clearance on 2001-10-03 under 510(k) number K013002. 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 CALIBRATION VERIFICATION CONTROLS, CATALOG #94002?

TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002 is a medical device that received FDA 510(k) clearance on 2001-10-03. The listed applicant is Biosite Incorporated. The 510(k) number is K013002.

When did TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002 receive FDA 510(k) clearance?

TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002 received FDA 510(k) clearance on 2001-10-03, under 510(k) number K013002.

Who is the listed applicant for TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002?

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 CALIBRATION VERIFICATION CONTROLS, CATALOG #94002?

The FDA product code for TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002 is DIF.

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Other records listing Biosite Incorporated as applicant

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Related Devices (Code: DIF)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.