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FDA 510(k)

HUMAN IGA2 KIT FOR USE ON THE SPAPLUS

K-Number: K100588 · 2010-08-16

ApplicantThe Binding Site Group , Ltd.
Decision Date2010-08-16
Product CodeCFN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HUMAN IGA2 KIT FOR USE ON THE SPAPLUS is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site Group , Ltd.. It received FDA 510(k) clearance on 2010-08-16 under 510(k) number K100588. 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 IGA2 KIT FOR USE ON THE SPAPLUS?

HUMAN IGA2 KIT FOR USE ON THE SPAPLUS is a medical device that received FDA 510(k) clearance on 2010-08-16. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K100588.

When did HUMAN IGA2 KIT FOR USE ON THE SPAPLUS receive FDA 510(k) clearance?

HUMAN IGA2 KIT FOR USE ON THE SPAPLUS received FDA 510(k) clearance on 2010-08-16, under 510(k) number K100588.

Who is the listed applicant for HUMAN IGA2 KIT FOR USE ON THE SPAPLUS?

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

What is the FDA product code for HUMAN IGA2 KIT FOR USE ON THE SPAPLUS?

The FDA product code for HUMAN IGA2 KIT FOR USE ON THE SPAPLUS is CFN.

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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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