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FDA 510(k)

MICROMEDIC CRACKPOT RIA KIT

K-Number: K880674 · 1988-10-06

ApplicantIcn Micromedic Systems
Decision Date1988-10-06
Product CodeKLN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MICROMEDIC CRACKPOT RIA 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 1988-10-06 under 510(k) number K880674. The device is classified under product code KLN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROMEDIC CRACKPOT RIA KIT?

MICROMEDIC CRACKPOT RIA KIT is a medical device that received FDA 510(k) clearance on 1988-10-06. The listed applicant is Icn Micromedic Systems. The 510(k) number is K880674.

When did MICROMEDIC CRACKPOT RIA KIT receive FDA 510(k) clearance?

MICROMEDIC CRACKPOT RIA KIT received FDA 510(k) clearance on 1988-10-06, under 510(k) number K880674.

Who is the listed applicant for MICROMEDIC CRACKPOT RIA 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 CRACKPOT RIA KIT?

The FDA product code for MICROMEDIC CRACKPOT RIA KIT is KLN.

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 38010K883746MICROMEDIC FERRITIN IRMA KITK881102MICROMEDIC MORPHINE RIA KIT

Related Devices (Code: KLN)

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.

K010868PSYCHEMEDICS RIA COCAINE ASSAYPsychemedics Corp.K913867URINE COCAINE METABOLITE DIRECT RIA KIT (I-125)Immunalysis CorporationK913722ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITERoche Diagnostic Systems, Inc.K912756ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITERoche Diagnostic Systems, Inc.K910123TARGET COCAINE METABOLITE-VV-Tech, Inc.K910122TARGET COCAINE METABOLITE-RV-Tech, Inc.

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.

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