Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR

K-Number: K014173 · 2002-02-15

ApplicantBeckman Coulter, Inc.
Decision Date2002-02-15
Product CodeDKJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2002-02-15 under 510(k) number K014173. 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 SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR?

SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR is a medical device that received FDA 510(k) clearance on 2002-02-15. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K014173.

When did SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR receive FDA 510(k) clearance?

SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR received FDA 510(k) clearance on 2002-02-15, under 510(k) number K014173.

Who is the listed applicant for SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR?

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

What is the FDA product code for SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR?

The FDA product code for SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR is DKJ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Beckman Coulter, 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.

K262109Access NT-proBNPK252169Access BNP IIK254059Access anti-HBc IgMK253687Access anti-HBc TotalK251995Access anti-HAV IgMK250588Access Rubella IgG

View all 261 devices →

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.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.

↑