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FDA 510(k)

EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95

K-Number: K872330 · 1987-07-09

ApplicantEm Diagnostic Systems, Inc.
Decision Date1987-07-09
Product CodeDKJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95 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 1987-07-09 under 510(k) number K872330. The device is classified under product code DKJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95?

EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95 is a medical device that received FDA 510(k) clearance on 1987-07-09. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K872330.

When did EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95 receive FDA 510(k) clearance?

EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95 received FDA 510(k) clearance on 1987-07-09, under 510(k) number K872330.

Who is the listed applicant for EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95?

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 EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95?

The FDA product code for EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95 is DKJ.

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Other records listing Em Diagnostic Systems, Inc. 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.

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: DKJ)

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.

K093939ADVIA CHEMISTRY SALICYLATE REAGENTSiemens Healthcare DiagnosticsK042329SALICYLATE-SL ASSAYDiagnostic Chemicals , Ltd.K020794SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMBayer Diagnostics Corp.K014173SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATORBeckman Coulter, Inc.K011878EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109ULSyva Co.K981872SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40Diagnostic Chemicals , Ltd.

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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