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)

HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS

K-Number: K103824 · 2012-02-27

ApplicantThe Binding Site
Decision Date2012-02-27
Product CodeCFN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site. It received FDA 510(k) clearance on 2012-02-27 under 510(k) number K103824. The device is classified under product code CFN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS?

HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS is a medical device that received FDA 510(k) clearance on 2012-02-27. The listed applicant is The Binding Site. The 510(k) number is K103824.

When did HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS receive FDA 510(k) clearance?

HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS received FDA 510(k) clearance on 2012-02-27, under 510(k) number K103824.

Who is the listed applicant for HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS?

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

What is the FDA product code for HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS?

The FDA product code for HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS is CFN.

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 The Binding Site 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.

K132555HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KITK100455SPAPLUS ANALYZERK092450HUMAN IGD KIT FOR USE ON SPAPLUSK072166CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZERK042579BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KITK042152BINDING SITE IGG SUBLCASS OLYMPUS KITS

View all 9 devices →

Related Devices (Code: CFN)

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.

K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbHK221114Immunoglobulin G (IgG)Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K192116Human IgA liquid reagent kit for Use on SPAPlusThe Binding Site Group , Ltd.K191985Optilite IgA KitThe Binding Site Group , Ltd.K191635Optilite IgM KitThe Binding Site Group , Ltd.K191465Human IgM Kit for use on SPAPlusThe Binding Site Group , 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.

↑