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FDA 510(k)

BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE

K-Number: K914146 · 1991-10-11

ApplicantBiosite Incorporated
Decision Date1991-10-11
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE is the device name listed in this FDA 510(k) record. The listed applicant is Biosite Incorporated. It received FDA 510(k) clearance on 1991-10-11 under 510(k) number K914146. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE?

BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE is a medical device that received FDA 510(k) clearance on 1991-10-11. The listed applicant is Biosite Incorporated. The 510(k) number is K914146.

When did BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE receive FDA 510(k) clearance?

BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE received FDA 510(k) clearance on 1991-10-11, under 510(k) number K914146.

Who is the listed applicant for BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE?

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 BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE?

The FDA product code for BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE is DKZ.

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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.

K092987INRATIO/INRATIO2 TEST STRIPSK092048ONE STEP EDDP (METHADONE METABOLITE) TEST STRIPK093032TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SETK080269TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELSK072892TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5K062840TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS

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Related Devices (Code: DKZ)

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.

K240670DRI Ecstasy Plus AssayMicrogenics CorporationK233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxHangzhou AllTest Biotech Co., Ltd.K231137Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science Co., Ltd.K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc.K191099Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test PanelAtlas MedicalK182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc.

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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