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)

ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL

K-Number: K082638 · 2009-02-26

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2009-02-26
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2009-02-26 under 510(k) number K082638. The device is classified under product code KLI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL?

ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL is a medical device that received FDA 510(k) clearance on 2009-02-26. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K082638.

When did ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL receive FDA 510(k) clearance?

ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL received FDA 510(k) clearance on 2009-02-26, under 510(k) number K082638.

Who is the listed applicant for ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL?

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

What is the FDA product code for ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL?

The FDA product code for ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL is KLI.

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 Siemens Healthcare Diagnostics, 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.

K253528Atellica IM CA 19-9 IIK261364Atellica CH Acetaminophen 2 (ACTM)K251998Atellica CH Diazo Total Bilirubin (D_TBil)K251543Atellica® IM TSH3-Ultra II (TSH3ULII)K251630Atellica IM Total PSA II (tPSAII)K250816ADVIA Centaur Anti-Thyroglobulin II (aTgII)

View all 114 devices →

Related Devices (Code: KLI)

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.

K160495VITROS® Automation SolutionsOrtho-Clinical Diagnostics, Inc.K131515ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENTAlfa WassermannK103484GSP NEONATAL THYROXINE (T4)Wallac Oy, A Subsidiary of Perkinelmer, Inc.K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300MonobindK023369ACCESS TOTAL T4 ASSAYBeckman Coulter, Inc.K001603REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105)Repromedix Corp.

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.

↑