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FDA 510(k)

MICROMEDIC FERRITIN IRMA KIT

K-Number: K883746 · 1988-10-27

ApplicantIcn Micromedic Systems
Decision Date1988-10-27
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MICROMEDIC FERRITIN IRMA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Icn Micromedic Systems. It received FDA 510(k) clearance on 1988-10-27 under 510(k) number K883746. The device is classified under product code DBF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROMEDIC FERRITIN IRMA KIT?

MICROMEDIC FERRITIN IRMA KIT is a medical device that received FDA 510(k) clearance on 1988-10-27. The listed applicant is Icn Micromedic Systems. The 510(k) number is K883746.

When did MICROMEDIC FERRITIN IRMA KIT receive FDA 510(k) clearance?

MICROMEDIC FERRITIN IRMA KIT received FDA 510(k) clearance on 1988-10-27, under 510(k) number K883746.

Who is the listed applicant for MICROMEDIC FERRITIN IRMA KIT?

The FDA 510(k) record lists Icn Micromedic Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROMEDIC FERRITIN IRMA KIT?

The FDA product code for MICROMEDIC FERRITIN IRMA KIT is DBF.

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 Icn Micromedic Systems 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.

K884269SAMPLE IDENTIFICATION STATION MODEL 38010K880674MICROMEDIC CRACKPOT RIA KITK881102MICROMEDIC MORPHINE RIA KIT

Related Devices (Code: DBF)

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.

K193650LIAISON FerritinDiaSorin, Inc.K191562Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactorHORIBA ABX SASK171642Atellica IM Ferritin AssaySiemens Healthcare Diagnostics, Inc.K121232K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATORKamiya Biomedical CompanyK110736ADVIA CHEMISTRY FERRITIN (FRT) METHODSiemens Healthcare Diagnostics, Inc.K100538TINA-QUANT FERRITIN GEN. 4Roche Diagnostics

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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