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FDA 510(k)

EASY-TEST SALICYLATE (SAL) #16691

K-Number: K873425 · 1987-10-29

ApplicantEm Diagnostic Systems, Inc.
Decision Date1987-10-29
Product CodeDKJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EASY-TEST SALICYLATE (SAL) #16691 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 1987-10-29 under 510(k) number K873425. 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 EASY-TEST SALICYLATE (SAL) #16691?

EASY-TEST SALICYLATE (SAL) #16691 is a medical device that received FDA 510(k) clearance on 1987-10-29. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K873425.

When did EASY-TEST SALICYLATE (SAL) #16691 receive FDA 510(k) clearance?

EASY-TEST SALICYLATE (SAL) #16691 received FDA 510(k) clearance on 1987-10-29, under 510(k) number K873425.

Who is the listed applicant for EASY-TEST SALICYLATE (SAL) #16691?

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 SALICYLATE (SAL) #16691?

The FDA product code for EASY-TEST SALICYLATE (SAL) #16691 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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