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FDA 510(k)

HUMAN CAERULOPLASMIN KIT

K-Number: K122965 · 2013-06-03

ApplicantThe Binding Site Group , Ltd.
Decision Date2013-06-03
Product CodeDDB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HUMAN CAERULOPLASMIN 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 2013-06-03 under 510(k) number K122965. The device is classified under product code DDB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMAN CAERULOPLASMIN KIT?

HUMAN CAERULOPLASMIN KIT is a medical device that received FDA 510(k) clearance on 2013-06-03. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K122965.

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

HUMAN CAERULOPLASMIN KIT received FDA 510(k) clearance on 2013-06-03, under 510(k) number K122965.

Who is the listed applicant for HUMAN CAERULOPLASMIN 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 CAERULOPLASMIN KIT?

The FDA product code for HUMAN CAERULOPLASMIN KIT is DDB.

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Related Devices (Code: DDB)

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.

K161508CeruloplasminBeckman Coulter Ireland, Inc.K053074N ANTISERA TO HUMAN CERULOPLASMINDade Behring, Inc.K964762IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENTBeckman Instruments, Inc.K913668CAERULOPLASMIN IMMUNOLOGICAL NL TEST KITThe Binding Site, Ltd.K895377QM300 CERULOPLASMIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.K860138NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUMSigma Diagnostics, Inc.

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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