FDA 510(k)

SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL

K-Number: K993981 · 2000-02-01

Decision Date2000-02-01

Product CodeJXN

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 2000-02-01 under 510(k) number K993981. The device is classified under product code JXN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL?

SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL is a medical device that received FDA 510(k) clearance on 2000-02-01. The listed applicant is Syva Co.. The 510(k) number is K993981.

When did SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL receive FDA 510(k) clearance?

SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL received FDA 510(k) clearance on 2000-02-01, under 510(k) number K993981.

Who is the listed applicant for SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL?

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 SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL?

The FDA product code for SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL is JXN.

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Other records listing Syva Co. as applicant

K011878EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL K012257EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 K011947EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL K011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 K011347EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 K993980SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL

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Related Devices (Code: JXN)

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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.