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FDA 510(k)

ADVANCE EMIT-CAD QUINIDINE ASSAY

K-Number: K822588 · 1982-09-17

ApplicantSyva Co.
Decision Date1982-09-17
Product CodeLBZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ADVANCE EMIT-CAD QUINIDINE 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 1982-09-17 under 510(k) number K822588. The device is classified under product code LBZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANCE EMIT-CAD QUINIDINE ASSAY?

ADVANCE EMIT-CAD QUINIDINE ASSAY is a medical device that received FDA 510(k) clearance on 1982-09-17. The listed applicant is Syva Co.. The 510(k) number is K822588.

When did ADVANCE EMIT-CAD QUINIDINE ASSAY receive FDA 510(k) clearance?

ADVANCE EMIT-CAD QUINIDINE ASSAY received FDA 510(k) clearance on 1982-09-17, under 510(k) number K822588.

Who is the listed applicant for ADVANCE EMIT-CAD QUINIDINE 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 ADVANCE EMIT-CAD QUINIDINE ASSAY?

The FDA product code for ADVANCE EMIT-CAD QUINIDINE ASSAY is LBZ.

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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: LBZ)

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.

K052826QMS QUINIDINE. QMS QUINIDINE CALIBRATORSSeradyn, Inc.K032332ROCHE ONLINE TDM QUINIDINERoche Diagnostics Corp.K011605EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229Syva Co., Dade Behring, Inc.K964116QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)Bayer Corp.K964212QUINIDINE ENZYME IMMUNOASSAYDiagnostic Reagents, Inc.K955568INNOFLUOR QUINIDINE ASSAY SYSTEMOxis Intl., 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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