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FDA 510(k)

AMPHETAMINES EIA ASSAY MODIFICATION

K-Number: K934891 · 1994-01-13

ApplicantDiagnostic Reagents, Inc.
Decision Date1994-01-13
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMPHETAMINES EIA ASSAY MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Reagents, Inc.. It received FDA 510(k) clearance on 1994-01-13 under 510(k) number K934891. 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 AMPHETAMINES EIA ASSAY MODIFICATION?

AMPHETAMINES EIA ASSAY MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-01-13. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K934891.

When did AMPHETAMINES EIA ASSAY MODIFICATION receive FDA 510(k) clearance?

AMPHETAMINES EIA ASSAY MODIFICATION received FDA 510(k) clearance on 1994-01-13, under 510(k) number K934891.

Who is the listed applicant for AMPHETAMINES EIA ASSAY MODIFICATION?

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

What is the FDA product code for AMPHETAMINES EIA ASSAY MODIFICATION?

The FDA product code for AMPHETAMINES EIA ASSAY MODIFICATION is DKZ.

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Other records listing Diagnostic Reagents, 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.

K983268MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAYK983812NAPA EIA ASSAYK983323DIGOXIN IMMUNOASSAYK983280VANCOMYCIN EIA ASSAYK983159DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLSK973102LIDOCAINE EIA ASSAY

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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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