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FDA 510(k)

EMIT ETS PLUS ETHYL ALCOHOL ASSAY

K-Number: K903228 · 1990-08-17

ApplicantSyva Co.
Decision Date1990-08-17
Product CodeDMI
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT ETS PLUS ETHYL ALCOHOL 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 1990-08-17 under 510(k) number K903228. The device is classified under product code DMI. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMIT ETS PLUS ETHYL ALCOHOL ASSAY?

EMIT ETS PLUS ETHYL ALCOHOL ASSAY is a medical device that received FDA 510(k) clearance on 1990-08-17. The listed applicant is Syva Co.. The 510(k) number is K903228.

When did EMIT ETS PLUS ETHYL ALCOHOL ASSAY receive FDA 510(k) clearance?

EMIT ETS PLUS ETHYL ALCOHOL ASSAY received FDA 510(k) clearance on 1990-08-17, under 510(k) number K903228.

Who is the listed applicant for EMIT ETS PLUS ETHYL ALCOHOL 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 ETS PLUS ETHYL ALCOHOL ASSAY?

The FDA product code for EMIT ETS PLUS ETHYL ALCOHOL ASSAY is DMI.

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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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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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