FDA 510(k)

Optilite High Sensitivity C-Reactive Protein Kit

K-번호: K180099 · 2018-10-12

결정일2018-10-12

제품 코드DCN

자문 위원회IM

결정Substantially Equivalent

기기 요약

Optilite High Sensitivity C-Reactive Protein 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 2018-10-12 under 510(k) number K180099. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Optilite High Sensitivity C-Reactive Protein Kit?

Optilite High Sensitivity C-Reactive Protein Kit is a medical device that received FDA 510(k) clearance on 2018-10-12. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K180099.

When did Optilite High Sensitivity C-Reactive Protein Kit receive FDA 510(k) clearance?

Optilite High Sensitivity C-Reactive Protein Kit received FDA 510(k) clearance on 2018-10-12, under 510(k) number K180099.

Who is the listed applicant for Optilite High Sensitivity C-Reactive Protein 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 High Sensitivity C-Reactive Protein Kit?

The FDA product code for Optilite High Sensitivity C-Reactive Protein Kit is DCN.

The Binding Site Group , Ltd.를 신청인으로 등재한 기타 기록

K250159Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser K250549Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit K192116Human IgA liquid reagent kit for Use on SPAPlus K191985Optilite IgA Kit K191635Optilite IgM Kit K191465Human IgM Kit for use on SPAPlus

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