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FDA 510(k)

EASY-TEST QUINIDINE ITEM NO. 67---/95

K-Number: K864607 · 1987-01-08

ApplicantEm Diagnostic Systems, Inc.
Decision Date1987-01-08
Product CodeLBZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EASY-TEST QUINIDINE ITEM NO. 67---/95 is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1987-01-08 under 510(k) number K864607. 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 EASY-TEST QUINIDINE ITEM NO. 67---/95?

EASY-TEST QUINIDINE ITEM NO. 67---/95 is a medical device that received FDA 510(k) clearance on 1987-01-08. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K864607.

When did EASY-TEST QUINIDINE ITEM NO. 67---/95 receive FDA 510(k) clearance?

EASY-TEST QUINIDINE ITEM NO. 67---/95 received FDA 510(k) clearance on 1987-01-08, under 510(k) number K864607.

Who is the listed applicant for EASY-TEST QUINIDINE ITEM NO. 67---/95?

The FDA 510(k) record lists Em Diagnostic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EASY-TEST QUINIDINE ITEM NO. 67---/95?

The FDA product code for EASY-TEST QUINIDINE ITEM NO. 67---/95 is LBZ.

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Other records listing Em Diagnostic Systems, Inc. as applicant

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K935181ASPARTATE AMINOTRANSFERASE (AST) TESTK935180ALANINE AMINOTRANSFERASE (ALT) TESTK935178EMDS PHOSPHOROUS (PHOS) TESTK935179EMDS ALBUMIN (ALB) TESTK935175LACTATE DEHYDROGENASE (LD)K935174TOTAL PROTEIN TEST (TPRO)

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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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