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FDA 510(k)

BINDING SITE IGG SUBLCASS OLYMPUS KITS

K-Number: K042152 · 2004-11-22

ApplicantThe Binding Site
Decision Date2004-11-22
Product CodeCFN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BINDING SITE IGG SUBLCASS OLYMPUS KITS 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 2004-11-22 under 510(k) number K042152. 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 BINDING SITE IGG SUBLCASS OLYMPUS KITS?

BINDING SITE IGG SUBLCASS OLYMPUS KITS is a medical device that received FDA 510(k) clearance on 2004-11-22. The listed applicant is The Binding Site. The 510(k) number is K042152.

When did BINDING SITE IGG SUBLCASS OLYMPUS KITS receive FDA 510(k) clearance?

BINDING SITE IGG SUBLCASS OLYMPUS KITS received FDA 510(k) clearance on 2004-11-22, under 510(k) number K042152.

Who is the listed applicant for BINDING SITE IGG SUBLCASS OLYMPUS KITS?

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 BINDING SITE IGG SUBLCASS OLYMPUS KITS?

The FDA product code for BINDING SITE IGG SUBLCASS OLYMPUS KITS is CFN.

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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 KITK103824HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUSK100455SPAPLUS ANALYZERK092450HUMAN IGD KIT FOR USE ON SPAPLUSK072166CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZERK042579BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT

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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.

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