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FDA 510(k)

MICROLINE SCREEN FOR AMPHETAMINE

K-Number: K935052 · 1994-09-16

ApplicantDrug Screening Systems, Inc.
Decision Date1994-09-16
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MICROLINE SCREEN FOR AMPHETAMINE is the device name listed in this FDA 510(k) record. The listed applicant is Drug Screening Systems, Inc.. It received FDA 510(k) clearance on 1994-09-16 under 510(k) number K935052. 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 MICROLINE SCREEN FOR AMPHETAMINE?

MICROLINE SCREEN FOR AMPHETAMINE is a medical device that received FDA 510(k) clearance on 1994-09-16. The listed applicant is Drug Screening Systems, Inc.. The 510(k) number is K935052.

When did MICROLINE SCREEN FOR AMPHETAMINE receive FDA 510(k) clearance?

MICROLINE SCREEN FOR AMPHETAMINE received FDA 510(k) clearance on 1994-09-16, under 510(k) number K935052.

Who is the listed applicant for MICROLINE SCREEN FOR AMPHETAMINE?

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

What is the FDA product code for MICROLINE SCREEN FOR AMPHETAMINE?

The FDA product code for MICROLINE SCREEN FOR AMPHETAMINE is DKZ.

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Other records listing Drug Screening Systems, Inc. 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.

K945829MICROLINE SCREEN FOR BENZODIAZEPINEK933480MICROLINE SCREEN FOR BARBITURATESK921651MICROLINE SCREEN FOR PHENCYCLIDINEK914915MICROLINE SCREEN FOR CANNABINOIDK911652MIRCOLINE SCREEN FOR COCAINEK910525MICROLINE SCREEN FOR METHAMPHETAMINE

View all 8 devices →

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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