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FDA 510(k)

EMIT(R) IIC AMPHETAMINE ASSAY

K-Number: K935352 · 1995-02-22

ApplicantSyva Co.
Decision Date1995-02-22
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT(R) IIC AMPHETAMINE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1995-02-22 under 510(k) number K935352. 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 EMIT(R) IIC AMPHETAMINE ASSAY?

EMIT(R) IIC AMPHETAMINE ASSAY is a medical device that received FDA 510(k) clearance on 1995-02-22. The listed applicant is Syva Co.. The 510(k) number is K935352.

When did EMIT(R) IIC AMPHETAMINE ASSAY receive FDA 510(k) clearance?

EMIT(R) IIC AMPHETAMINE ASSAY received FDA 510(k) clearance on 1995-02-22, under 510(k) number K935352.

Who is the listed applicant for EMIT(R) IIC AMPHETAMINE ASSAY?

The FDA 510(k) record lists Syva Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMIT(R) IIC AMPHETAMINE ASSAY?

The FDA product code for EMIT(R) IIC AMPHETAMINE ASSAY is DKZ.

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Other records listing Syva Co. 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.

K011878EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109ULK012257EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229K011947EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229ULK011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229K011347EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229K993980SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL

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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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