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FDA 510(k)

HUMAN ALBUMIN CSF KIT

K-Number: K121045 · 2013-06-19

ApplicantThe Binding Site Group , Ltd.
Decision Date2013-06-19
Product CodeDCF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HUMAN ALBUMIN 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 2013-06-19 under 510(k) number K121045. 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 HUMAN ALBUMIN CSF KIT?

HUMAN ALBUMIN CSF KIT is a medical device that received FDA 510(k) clearance on 2013-06-19. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K121045.

When did HUMAN ALBUMIN CSF KIT receive FDA 510(k) clearance?

HUMAN ALBUMIN CSF KIT received FDA 510(k) clearance on 2013-06-19, under 510(k) number K121045.

Who is the listed applicant for HUMAN ALBUMIN 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 HUMAN ALBUMIN CSF KIT?

The FDA product code for HUMAN ALBUMIN CSF KIT is DCF.

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Related Devices (Code: 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.

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