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FDA 510(k)

MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY

K-Number: K833623 · 1983-12-08

ApplicantSyva Co.
Decision Date1983-12-08
Product CodeKLR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MODIF. OF EMIT CAD DISOPYRAMIDE 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 1983-12-08 under 510(k) number K833623. The device is classified under product code KLR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY?

MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY is a medical device that received FDA 510(k) clearance on 1983-12-08. The listed applicant is Syva Co.. The 510(k) number is K833623.

When did MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY receive FDA 510(k) clearance?

MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY received FDA 510(k) clearance on 1983-12-08, under 510(k) number K833623.

Who is the listed applicant for MODIF. OF EMIT CAD DISOPYRAMIDE 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 MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY?

The FDA product code for MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY is KLR.

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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: KLR)

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.

K090282QMS LIDOCAINEThermo Fisher Scientific, Inc.K033809DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49DDade Behring, Inc.K032334ROCHE ONLINE TDM LIDOCAINERoche Diagnostics Corp.K973102LIDOCAINE EIA ASSAYDiagnostic Reagents, Inc.K881116EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641Diagnostic SystemsK853010COBAS REAGENT FOR LIDOCAINE & CALIBRATORSRoche Diagnostic Systems, 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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