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FDA 510(k)

EZ-SCREEN: AMPHETAMINES

K-Number: K905700 · 1991-01-15

ApplicantEnvironmental Diagnostics, Inc.
Decision Date1991-01-15
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EZ-SCREEN: AMPHETAMINES is the device name listed in this FDA 510(k) record. The listed applicant is Environmental Diagnostics, Inc.. It received FDA 510(k) clearance on 1991-01-15 under 510(k) number K905700. 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 EZ-SCREEN: AMPHETAMINES?

EZ-SCREEN: AMPHETAMINES is a medical device that received FDA 510(k) clearance on 1991-01-15. The listed applicant is Environmental Diagnostics, Inc.. The 510(k) number is K905700.

When did EZ-SCREEN: AMPHETAMINES receive FDA 510(k) clearance?

EZ-SCREEN: AMPHETAMINES received FDA 510(k) clearance on 1991-01-15, under 510(k) number K905700.

Who is the listed applicant for EZ-SCREEN: AMPHETAMINES?

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

What is the FDA product code for EZ-SCREEN: AMPHETAMINES?

The FDA product code for EZ-SCREEN: AMPHETAMINES is DKZ.

Related Clinical Trials

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Other records listing Environmental Diagnostics, 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.

K905057EZ-SCREEN:BARBITURATESK902681EZ-SCREEN:HCGK900203EZ-SCREEN:OPIATESK883105EZ-SCREEN CANNABINOID/COCAINEK862916EZ-SCREEN: CANNABINOID

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

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

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