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FDA 510(k)

ADVIA CHEMISTRY SALICYLATE REAGENT

K-Number: K093939 · 2010-05-19

ApplicantSiemens Healthcare Diagnostics
Decision Date2010-05-19
Product CodeDKJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ADVIA CHEMISTRY SALICYLATE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2010-05-19 under 510(k) number K093939. 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 ADVIA CHEMISTRY SALICYLATE REAGENT?

ADVIA CHEMISTRY SALICYLATE REAGENT is a medical device that received FDA 510(k) clearance on 2010-05-19. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K093939.

When did ADVIA CHEMISTRY SALICYLATE REAGENT receive FDA 510(k) clearance?

ADVIA CHEMISTRY SALICYLATE REAGENT received FDA 510(k) clearance on 2010-05-19, under 510(k) number K093939.

Who is the listed applicant for ADVIA CHEMISTRY SALICYLATE REAGENT?

The FDA 510(k) record lists Siemens Healthcare Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVIA CHEMISTRY SALICYLATE REAGENT?

The FDA product code for ADVIA CHEMISTRY SALICYLATE REAGENT is DKJ.

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Other records listing Siemens Healthcare Diagnostics as applicant

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K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)K162977ADVIA 2120i, ADVIA 2120K162298LOCI Total Vitamin D Total Assay, LOCI VITD CALK161954Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)K162538ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorK151964Xprecia Stride Coagulation System, Xprecia System PT Controls

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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.

K042329SALICYLATE-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.K980032SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71Diagnostic 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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