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)

DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)

K-Number: K083339 · 2009-03-09

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2009-03-09
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) 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 2009-03-09 under 510(k) number K083339. The device is classified under product code CIC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)?

DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) is a medical device that received FDA 510(k) clearance on 2009-03-09. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K083339.

When did DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) receive FDA 510(k) clearance?

DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) received FDA 510(k) clearance on 2009-03-09, under 510(k) number K083339.

Who is the listed applicant for DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)?

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 DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)?

The FDA product code for DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) is CIC.

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: CIC)

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.

K130870HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)Hitachi Chemical Diagnostics, Inc.K070249ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/HHoriba AbxK053401SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTSArkray, Inc.K050077SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTSArkray, Inc.K041009RAICHEM CALCIUM (OCPC) LIQUID REAGENTHemagen Diagnostics, Inc.K023105ATAC CALCIUM REAGENT AND ATAC CALIBRATORElan Diagnostics

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.

↑