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FDA 510(k)

TRIAGE TOX DRUG SCREEN, MODEL 94400

K-Number: K060791 · 2006-06-22

ApplicantBiosite Incorporated
Decision Date2006-06-22
Product CodeDJR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TRIAGE TOX DRUG SCREEN, MODEL 94400 is the device name listed in this FDA 510(k) record. The listed applicant is Biosite Incorporated. It received FDA 510(k) clearance on 2006-06-22 under 510(k) number K060791. The device is classified under product code DJR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIAGE TOX DRUG SCREEN, MODEL 94400?

TRIAGE TOX DRUG SCREEN, MODEL 94400 is a medical device that received FDA 510(k) clearance on 2006-06-22. The listed applicant is Biosite Incorporated. The 510(k) number is K060791.

When did TRIAGE TOX DRUG SCREEN, MODEL 94400 receive FDA 510(k) clearance?

TRIAGE TOX DRUG SCREEN, MODEL 94400 received FDA 510(k) clearance on 2006-06-22, under 510(k) number K060791.

Who is the listed applicant for TRIAGE TOX DRUG SCREEN, MODEL 94400?

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, MODEL 94400?

The FDA product code for TRIAGE TOX DRUG SCREEN, MODEL 94400 is DJR.

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Other records listing Biosite Incorporated as applicant

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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Related Devices (Code: DJR)

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K192433LZI Methadone II Enzyme ImmunoassayLin-Zhi International, Inc.K182779ARK EDDP AssayArk Diagnostics, Inc.K170416LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) CalibratorsLin-Zhi International, Inc.K160793First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)W.H.P.M., Inc.K131232WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)Guangzhou Wondfo Biotech Co., Ltd.K092272RANDOX METHADONE ASSAYRandox Laboratories, Ltd.

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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