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FDA 510(k)

Optilite IgA Kit

K-Number: K191985 · 2019-08-19

ApplicantThe Binding Site Group , Ltd.
Decision Date2019-08-19
Product CodeCFN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Optilite IgA 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 2019-08-19 under 510(k) number K191985. 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 Optilite IgA Kit?

Optilite IgA Kit is a medical device that received FDA 510(k) clearance on 2019-08-19. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K191985.

When did Optilite IgA Kit receive FDA 510(k) clearance?

Optilite IgA Kit received FDA 510(k) clearance on 2019-08-19, under 510(k) number K191985.

Who is the listed applicant for Optilite IgA 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 Optilite IgA Kit?

The FDA product code for Optilite IgA Kit is CFN.

Other records listing The Binding Site Group , Ltd. 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.

K250159Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserK250549Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitK192116Human IgA liquid reagent kit for Use on SPAPlusK191635Optilite IgM KitK191465Human IgM Kit for use on SPAPlusK190686Optilite IgM CSF 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.K191635Optilite IgM KitThe Binding Site Group , Ltd.K191465Human IgM Kit for use on SPAPlusThe Binding Site Group , Ltd.K190686Optilite IgM CSF KitThe 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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