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FDA 510(k)

IBL C3D-CIC EIA TEST

K-Number: K032796 · 2004-01-13

ApplicantIbl GmbH
Decision Date2004-01-13
Product CodeCZW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IBL C3D-CIC EIA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Ibl GmbH. It received FDA 510(k) clearance on 2004-01-13 under 510(k) number K032796. 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 IBL C3D-CIC EIA TEST?

IBL C3D-CIC EIA TEST is a medical device that received FDA 510(k) clearance on 2004-01-13. The listed applicant is Ibl GmbH. The 510(k) number is K032796.

When did IBL C3D-CIC EIA TEST receive FDA 510(k) clearance?

IBL C3D-CIC EIA TEST received FDA 510(k) clearance on 2004-01-13, under 510(k) number K032796.

Who is the listed applicant for IBL C3D-CIC EIA TEST?

The FDA 510(k) record lists Ibl GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IBL C3D-CIC EIA TEST?

The FDA product code for IBL C3D-CIC EIA TEST is CZW.

Other records listing Ibl GmbH 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.

K051969TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIAK041349LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUMK040923LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVAK033786LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVAK032254IBL C1Q-CIC CIA TEST

Related Devices (Code: CZW)

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.

K100179SPAPLUSThe Binding Site Group , Ltd.K063150COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROLThermo Electron OYK061852DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGHDade Behring, Inc.K050665N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)Dade Behring, Inc.K042494VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND IIIOrtho-Clinical DiagnosticsK032035SYNCHRON 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.

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