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)

KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT

K-Number: K073590 · 2008-04-10

ApplicantKronus Market Development Associates, Inc.
Decision Date2008-04-10
Product CodeOIF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Kronus Market Development Associates, Inc.. It received FDA 510(k) clearance on 2008-04-10 under 510(k) number K073590. The device is classified under product code OIF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT?

KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT is a medical device that received FDA 510(k) clearance on 2008-04-10. The listed applicant is Kronus Market Development Associates, Inc.. The 510(k) number is K073590.

When did KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT receive FDA 510(k) clearance?

KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT received FDA 510(k) clearance on 2008-04-10, under 510(k) number K073590.

Who is the listed applicant for KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT?

The FDA 510(k) record lists Kronus Market Development Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT?

The FDA product code for KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT is OIF.

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 Kronus Market Development Associates, 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.

K121046STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KITK111956KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KITK080523KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KITK080159KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KITK072135KRONUS GAD AUTOANTIBODY ELISA ASSAY KITK070183KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT

View all 10 devices →

Related Devices (Code: OIF)

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.

K220085KRONUS IA-2 Autoantibody (IA-2Ab) ELISA KitKronus, Inc.K171731KRONUS IA-2 Autoantibody (IA-2Ab) ELISA KitKronus, 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.

↑