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FDA 510(k)

EMIT II BENZODIAZEPINE ASSAY

K-Number: K910376 · 1991-02-22

ApplicantSyva Co.
Decision Date1991-02-22
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT II BENZODIAZEPINE 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 1991-02-22 under 510(k) number K910376. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMIT II BENZODIAZEPINE ASSAY?

EMIT II BENZODIAZEPINE ASSAY is a medical device that received FDA 510(k) clearance on 1991-02-22. The listed applicant is Syva Co.. The 510(k) number is K910376.

When did EMIT II BENZODIAZEPINE ASSAY receive FDA 510(k) clearance?

EMIT II BENZODIAZEPINE ASSAY received FDA 510(k) clearance on 1991-02-22, under 510(k) number K910376.

Who is the listed applicant for EMIT II BENZODIAZEPINE 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 II BENZODIAZEPINE ASSAY?

The FDA product code for EMIT II BENZODIAZEPINE ASSAY is JXM.

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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: JXM)

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.

K243498Alinity c Benzodiazepines Reagent KitMicrogenics CorporationK221765ONLINE DAT Benzodiazepines IIRoche DiagnosticsK190968CEDIA Benzodiazepine AssayMicrogenics CorporationK173963DRI Benzodiazepine AssayMicrogenics CorporationK163590Psychemedics Microplate EIA for Benzodiazepines in HairPsychemedics CorporationK163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC

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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