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 LX SYSTEMS MICROALBUMIN CALIBRATOR

K-Number: K000331 · 2000-02-10

ApplicantBeckman Coulter, Inc.
Decision Date2000-02-10
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNCHRON LX SYSTEMS MICROALBUMIN 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 2000-02-10 under 510(k) number K000331. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR?

SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR is a medical device that received FDA 510(k) clearance on 2000-02-10. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K000331.

When did SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR receive FDA 510(k) clearance?

SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR received FDA 510(k) clearance on 2000-02-10, under 510(k) number K000331.

Who is the listed applicant for SYNCHRON LX SYSTEMS MICROALBUMIN 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 LX SYSTEMS MICROALBUMIN CALIBRATOR?

The FDA product code for SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR is JIS.

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: JIS)

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.

K122126DIRECT LDL/HDL CHOLESTEROL CALIBRATORRandox Laboratories LimitedK061251DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATORDade Behring, Inc.K060266DIMENSION IRON CALIBRATORDade Behring, Inc.K053104DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATORDade Behring, Inc.K032697DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)Dade Behring, Inc.K032608GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETERGonotec Gesellschaft Fuer Mess-Und Regeltechnik MB

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.

↑