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)

Optilite IgM CSF Kit

K-Number: K190686 · 2019-05-28

ApplicantThe Binding Site Group , Ltd.
Decision Date2019-05-28
Product CodeCFN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Optilite IgM CSF 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 2019-05-28 under 510(k) number K190686. 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 IgM CSF Kit?

Optilite IgM CSF Kit is a medical device that received FDA 510(k) clearance on 2019-05-28. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K190686.

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

Optilite IgM CSF Kit received FDA 510(k) clearance on 2019-05-28, under 510(k) number K190686.

Who is the listed applicant for Optilite IgM CSF 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 IgM CSF Kit?

The FDA product code for Optilite IgM CSF 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 SPAPlusK191985Optilite IgA KitK191635Optilite IgM KitK191465Human IgM Kit for use on SPAPlus

View all 18 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.

↑