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FDA 510(k)

AMPHETAMINE TEST SYSTEM

K-Number: K934693 · 1993-11-22

ApplicantU.S. Drug Testing, Inc.
Decision Date1993-11-22
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMPHETAMINE TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is U.S. Drug Testing, Inc.. It received FDA 510(k) clearance on 1993-11-22 under 510(k) number K934693. 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 AMPHETAMINE TEST SYSTEM?

AMPHETAMINE TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1993-11-22. The listed applicant is U.S. Drug Testing, Inc.. The 510(k) number is K934693.

When did AMPHETAMINE TEST SYSTEM receive FDA 510(k) clearance?

AMPHETAMINE TEST SYSTEM received FDA 510(k) clearance on 1993-11-22, under 510(k) number K934693.

Who is the listed applicant for AMPHETAMINE TEST SYSTEM?

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

What is the FDA product code for AMPHETAMINE TEST SYSTEM?

The FDA product code for AMPHETAMINE TEST SYSTEM is DKZ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing U.S. Drug Testing, 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.

K940912USDT CANNABINOID (THC) ASSAY COLUMN CATALOG NO. 9000-500K935629USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400K932318USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200K931227USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000K930985USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100

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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