FDA 510(k)

Optilite Low Level Albumin Kit

K-Number: K153560 · 2016-08-25

Decision Date2016-08-25

Product CodeDCF

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

Optilite Low Level Albumin Kit is a medical device manufactured by The Binding Site Group , Ltd.. It received FDA 510(k) clearance on 2016-08-25 under approval number K153560. The device is classified under product code DCF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Optilite Low Level Albumin Kit?

Optilite Low Level Albumin Kit is a medical device that received FDA 510(k) clearance on 2016-08-25. It is manufactured by The Binding Site Group , Ltd.. The 510(k) number is K153560.

When was Optilite Low Level Albumin Kit approved by the FDA?

Optilite Low Level Albumin Kit received FDA 510(k) clearance on 2016-08-25, under approval number K153560.

What company makes Optilite Low Level Albumin Kit?

Optilite Low Level Albumin Kit is manufactured by The Binding Site Group , Ltd..

What is the FDA product code for Optilite Low Level Albumin Kit?

The FDA product code for Optilite Low Level Albumin Kit is DCF.

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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.