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)

I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT

K-Number: K871194 · 1987-04-20

ApplicantCronus
Decision Date1987-04-20
Product CodeDBL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Cronus. It received FDA 510(k) clearance on 1987-04-20 under 510(k) number K871194. The device is classified under product code DBL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT?

I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT is a medical device that received FDA 510(k) clearance on 1987-04-20. The listed applicant is Cronus. The 510(k) number is K871194.

When did I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT receive FDA 510(k) clearance?

I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT received FDA 510(k) clearance on 1987-04-20, under 510(k) number K871194.

Who is the listed applicant for I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT?

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

What is the FDA product code for I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT?

The FDA product code for I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT is DBL.

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 Cronus 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.

K871193I-125 ANTI-THYROGLOBULIN ANTIBODY IRMA TEST KITK863006125-I TSH RECEPTOR ANTIBODY KIT

Related Devices (Code: DBL)

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.

K180202Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno ConceptsImmuno Concepts, N.A. , Ltd.K980312NOVA LITE ENDOMYSIALInova Diagnostics, Inc.K974169WIELISA ANTI-GBM TEST SYSTEMWieslab ABK971464IMMUNOSCAN ANTI-GBM QUANTITATIVE KITEuro-Diagnostica ABK971658MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KITJay H. GellerK963525DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KITShield Diagnostics, Ltd.

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.

↑