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FDA 510(k)

C3 ANTISERUM CONTROL

K-Number: K834604 · 1984-01-24

ApplicantTechnicon Instruments Corp.
Decision Date1984-01-24
Product CodeCZW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

C3 ANTISERUM CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1984-01-24 under 510(k) number K834604. 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 C3 ANTISERUM CONTROL?

C3 ANTISERUM CONTROL is a medical device that received FDA 510(k) clearance on 1984-01-24. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K834604.

When did C3 ANTISERUM CONTROL receive FDA 510(k) clearance?

C3 ANTISERUM CONTROL received FDA 510(k) clearance on 1984-01-24, under 510(k) number K834604.

Who is the listed applicant for C3 ANTISERUM CONTROL?

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

What is the FDA product code for C3 ANTISERUM CONTROL?

The FDA product code for C3 ANTISERUM CONTROL is CZW.

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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 DiagnosticsK032796IBL C3D-CIC EIA TESTIbl GmbH

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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