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FDA 510(k)

Optilite Low Level Albumin Kit

K-Number: K153560 · 2016-08-25

ApplicantThe Binding Site Group , Ltd.
Decision Date2016-08-25
Product CodeDCF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Optilite Low Level Albumin 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 2016-08-25 under 510(k) 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. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K153560.

When did Optilite Low Level Albumin Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for Optilite Low Level Albumin 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 Low Level Albumin Kit?

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

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.

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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.

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