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FDA 510(k)

Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit

K-Number: K173732 · 2018-08-23

ApplicantThe Binding Site Group , Ltd.
Decision Date2018-08-23
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit is a medical device manufactured by The Binding Site Group , Ltd.. It received FDA 510(k) clearance on 2018-08-23 under approval number K173732. The device is classified under product code DFH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit?

Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit is a medical device that received FDA 510(k) clearance on 2018-08-23. It is manufactured by The Binding Site Group , Ltd.. The 510(k) number is K173732.

When was Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit approved by the FDA?

Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit received FDA 510(k) clearance on 2018-08-23, under approval number K173732.

What company makes Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit?

Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit is manufactured by The Binding Site Group , Ltd..

What is the FDA product code for Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit?

The FDA product code for Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit is DFH.

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Related Devices (Code: DFH)

K153394Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain CalibratorDiazyme Laboratories K171742N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2Siemens Healthcare Diagnostics Products GmbH K182098N Latex FLC kappa assay, N Latex FLC lambda assaySiemens Healthcare Diagnostics Products GmbH K181438Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain AssayDiazyme Laboratories, Inc. K190879N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH K201496N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH

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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