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FDA 510(k)

HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT

K-Number: K113823 · 2013-03-27

ApplicantThe Binding Site Group , Ltd.
Decision Date2013-03-27
Product CodeCFN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT 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 2013-03-27 under 510(k) number K113823. 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 HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT?

HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT is a medical device that received FDA 510(k) clearance on 2013-03-27. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K113823.

When did HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT receive FDA 510(k) clearance?

HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT received FDA 510(k) clearance on 2013-03-27, under 510(k) number K113823.

Who is the listed applicant for HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT?

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 HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT?

The FDA product code for HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT is CFN.

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Other records listing The Binding Site Group , Ltd. as applicant

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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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