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)

AURAFLEX B2-MICROGLOBULIN

K-Number: K944846 · 1995-06-20

ApplicantOrganon Teknika Corp.
Decision Date1995-06-20
Product CodeJZG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AURAFLEX B2-MICROGLOBULIN is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1995-06-20 under 510(k) number K944846. The device is classified under product code JZG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AURAFLEX B2-MICROGLOBULIN?

AURAFLEX B2-MICROGLOBULIN is a medical device that received FDA 510(k) clearance on 1995-06-20. The listed applicant is Organon Teknika Corp.. The 510(k) number is K944846.

When did AURAFLEX B2-MICROGLOBULIN receive FDA 510(k) clearance?

AURAFLEX B2-MICROGLOBULIN received FDA 510(k) clearance on 1995-06-20, under 510(k) number K944846.

Who is the listed applicant for AURAFLEX B2-MICROGLOBULIN?

The FDA 510(k) record lists Organon Teknika Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AURAFLEX B2-MICROGLOBULIN?

The FDA product code for AURAFLEX B2-MICROGLOBULIN is JZG.

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 Organon Teknika Corp. 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.

K003104BACT/ALERT CSRK000492MDA D-DIMERK000378BACT/ALERT MB CULTURE BOTTLEK994343BACT/ALERT SVK993423BACT/ALERT SAK993421BACT/ALERT SN

View all 130 devices →

Related Devices (Code: JZG)

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.

K161297Beta-2-MicroglobulinBeckman Coulter Ireland, Inc.K122066HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUSThe Binding Site Group , Ltd.K110874ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATORSiemens Healthcare Diagnostics, Inc.K083289HUMAN BETA-2 MICROGLOBULIN KITThe Binding Site, Ltd.K083463DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL MSiemens Healthcare DiagnosticsK072078QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307Biokit, S.A.

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.

↑