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FDA 510(k)

SALICYLATE TEST

K-Number: K843180 · 1984-09-07

ApplicantSclavo, Inc.
Decision Date1984-09-07
Product CodeDKJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SALICYLATE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1984-09-07 under 510(k) number K843180. 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 SALICYLATE TEST?

SALICYLATE TEST is a medical device that received FDA 510(k) clearance on 1984-09-07. The listed applicant is Sclavo, Inc.. The 510(k) number is K843180.

When did SALICYLATE TEST receive FDA 510(k) clearance?

SALICYLATE TEST received FDA 510(k) clearance on 1984-09-07, under 510(k) number K843180.

Who is the listed applicant for SALICYLATE TEST?

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

What is the FDA product code for SALICYLATE TEST?

The FDA product code for SALICYLATE TEST is DKJ.

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Other records listing Sclavo, Inc. as applicant

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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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