FDA 510(k)

N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)

K-Number: K050665 · 2005-05-02

Decision Date2005-05-02

Product CodeCZW

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) 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 2005-05-02 under 510(k) number K050665. The device is classified under product code CZW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)?

N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) is a medical device that received FDA 510(k) clearance on 2005-05-02. The listed applicant is Dade Behring, Inc.. The 510(k) number is K050665.

When did N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) receive FDA 510(k) clearance?

N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) received FDA 510(k) clearance on 2005-05-02, under 510(k) number K050665.

Who is the listed applicant for N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)?

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 COMPLEMENT FACTORS (C3C, C4)?

The FDA product code for N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) is CZW.

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K100179SPAPLUSThe Binding Site Group , Ltd.K063150COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROLThermo Electron OY K061852DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGHDade Behring, Inc.K042494VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND IIIOrtho-Clinical Diagnostics K032796IBL C3D-CIC EIA TESTIbl GmbH K032035SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALIBeckman Coulter, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.