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FDA 510(k)

N ANTISERA TO HUMAN CERULOPLASMIN

K-Number: K053074 · 2006-03-16

ApplicantDade Behring, Inc.
Decision Date2006-03-16
Product CodeDDB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

N ANTISERA TO HUMAN CERULOPLASMIN is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2006-03-16 under 510(k) number K053074. 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 N ANTISERA TO HUMAN CERULOPLASMIN?

N ANTISERA TO HUMAN CERULOPLASMIN is a medical device that received FDA 510(k) clearance on 2006-03-16. The listed applicant is Dade Behring, Inc.. The 510(k) number is K053074.

When did N ANTISERA TO HUMAN CERULOPLASMIN receive FDA 510(k) clearance?

N ANTISERA TO HUMAN CERULOPLASMIN received FDA 510(k) clearance on 2006-03-16, under 510(k) number K053074.

Who is the listed applicant for N ANTISERA TO HUMAN CERULOPLASMIN?

The FDA 510(k) record lists Dade Behring, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for N ANTISERA TO HUMAN CERULOPLASMIN?

The FDA product code for N ANTISERA TO HUMAN CERULOPLASMIN 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.K122965HUMAN CAERULOPLASMIN KITThe Binding Site Group , Ltd.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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